Who is the manufacturer of Finapres Nova Noninvasive Hemodynamic Monitor?

Finapres Medical Systems B.V. filed the 510(k) submission for Finapres Nova Noninvasive Hemodynamic Monitor (K173916).

What is the FDA product code for Finapres Nova Noninvasive Hemodynamic Monitor?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Finapres Nova Noninvasive Hemodynamic Monitor?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Finapres Nova Noninvasive Hemodynamic Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Finapres Nova Noninvasive Hemodynamic Monitor

Q: What are the predicate devices for Finapres Nova Noninvasive Hemodynamic Monitor?

Finapres Nova (K141460); Finapres Nova (K160967).

K173916 · Finapres Medical Systems B.V. · DXN · Nov 6, 2018 · Cardiovascular

Device Facts

Record ID	K173916
Device Name	Finapres Nova Noninvasive Hemodynamic Monitor
Applicant	Finapres Medical Systems B.V.
Product Code	DXN · Cardiovascular
Decision Date	Nov 6, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapes NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm noninvasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in hospitals, clinics, and research centers.

Device Story

Device monitors arterial circulation via finger cuff; inputs include photoplethysmography (PPG) signals from finger; optional modules for ECG, SpO2, and upper-arm blood pressure calibration. Operates using Peñáz arterial volume-clamp method and Wesseling Physiocal criteria to maintain finger artery volume constant; pressure required to do so reflects arterial blood pressure. System consists of base station and Nano Core (FEU NC) wrist unit; FEU NC performs pressure generation and signal processing. Used by clinicians in hospitals/clinics. Output includes continuous blood pressure waveforms, heart rate, HRV, BRS, and cardiac output (requires thermal dilution calibration). Data aids hemodynamic assessment and clinical decision-making. Benefits include noninvasive, continuous monitoring of hemodynamic status.

Clinical Evidence

Clinical investigation performed per ISO 81060-2:2013 to validate blood pressure measurement accuracy against invasive reference. Hemodynamic parameters were calculated using both invasive reference and subject device. Results demonstrated compliance with accuracy requirements and substantial equivalence to predicate.

Technological Characteristics

Noninvasive hemodynamic monitor; uses arterial volume-clamp method (Peñáz) and Physiocal criteria. Components: base station, FEU NC wrist unit, finger cuffs. Materials: aluminum/plastic casing, TPU cable. Connectivity: wired interface between FEU NC and base station. Software: C++ firmware (ISO 62304 compliant) for signal processing and pressure control. Power: 100-240 Vac. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 80601-2-30.

Indications for Use

Indicated for patients >18 years requiring noninvasive blood pressure and hemodynamic monitoring. Used in hospitals, clinics, and research centers.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

Finapres Nova (K141460)
Finapres Nova (K160967)

Related Devices

K160967 — Finapres Nova Noninvasive Hemodynamic Monitor · Finapres Medical Systems B.V. · Apr 18, 2017
K140312 — EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM · Edwards Lifesciences, LLC · Jun 13, 2014
K072049 — CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS · Bmeye B.V. · Nov 29, 2007
K141460 — FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR · Finapres Medical Systems B.V. · Mar 20, 2015
K102968 — INFINITY CNAP SMARTPOD · Draeger Medical Systems, Inc. · Feb 18, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 6, 2018 Finapres Medical Systems B.V. Iris van Uitert Quality Manager, Finapres Medical Systems V.V. Institutenweg 25 Enschede, 7521 PH NI ### Re: K173916 Trade/Device Name: Finapres NOVA Noninvasive Hemodynamic Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSB, DQA, DRT Dated: September 24, 2018 Received: September 26, 2018 Dear Iris van Uitert: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/5 description: The image shows the text "Shawn W. Forrest -A" in a large, sans-serif font. The text is arranged in two lines, with "Shawn W." on the first line and "Forrest -A" on the second line. The background is a light blue color with a subtle pattern of lighter blue rectangles. sitally signed by Shawn W. Forres HHS OU=FDA OU=Peonle 342 19200300 100 1 1=130040334 e: 2018.11.06 11:21:49 -05'00 for: Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K173916 #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) Device Name Finapres NOVA Indications for Use (Describe) The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapes NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm noninvasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in hospitals, clinics, and research centers. | Type of Use (Select one or both, as applicable) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <table border="0"><tr><td>❌ Prescription Use (Part 21 CFR 801 Subpart D)</td><td>□ Over The Counter Use (21 CFR 801 Subpart G)</td></tr></table> | ❌ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over The Counter Use (21 CFR 801 Subpart G) | | ❌ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over The Counter Use (21 CFR 801 Subpart G) | | > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary # Change of front-end unit of Finapres Nova to front-end unit Nano Core (FEU NC) This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92. # 1. Submitter's information | Submitter: | Finapres Medical Systems B.V. Institutenweg 25 7521 PH Enschede The Netherlands Phone number: +31 88 115 2700 Fax Number: +31 20 609 0677 Operator Number: 9051428 Registration number: 3003803088 | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Iris van Uitert, PhD Quality Manager Phone number: +31 88 115 2700 E-mail:iris.van.uitert@finapres.com | Date of preparation: November 1, 2018 # 2. Device information Finapres NOVA | Trade name: | Finapres NOVA Noninvasive Hemodynamic Monitor | |---------------------------------------------------------|---------------------------------------------------------------------------------------------| | Common name(s) | Noninvasive Blood Pressure Monitor Hemodynamic Monitor Electrocardiograph Oximeter | | Classification name | See Table 1 | | Device classification | Class II | | 510(k) number under which it was previously cleared. | K141460 and K160967 | | | | Table 1. Classification name Finapres NOVA | | |--|--|--------------------------------------------|--| | | | | | | Classification name | 21 CFR Section | Product Code | |-------------------------------------------------------|----------------|--------------| | Noninvasive Blood Pressure Monitor Measurement System | 870.1130 | DXN | | Plethysmograph, Impedance | 870.2770 | DSB | | Oximeter | 870.2700 | DQA | | Cardiac monitor | 870.2300 | DRT | {4}------------------------------------------------ # 3. Predicate Device for the proposed change The Finapres NOVA remains substantially equivalent in design (methodology) and indications for use to the primary predicate shown in Table 2 The additional AT software module (not present in K141460) is substantially equivalent in design (methodology) to the software algorithms used on the secondary predicate shown in Table 2 The indications for use of the Finapres NOVA is substantially equivalent to the devices shown in Table 2 that has previously been cleared. Table 2. Primary and secondary predicate devices for the Finapres Nova with front-end unit Nano Core | Device name | Manufacturer | 510(k) | |--------------------------|--------------------------|---------| | Primary: Finapres Nova | Finapres Medical Systems | K141460 | | Secondary: Finapres Nova | Finapres Medical Systems | K160967 | ### 4. Description of the Finapres with FEU NC The Finapres NOVA with FEU NC is based on existing Finapres Medical Systems B.V. product: the Finapres Nova. The changes between the Finapres NOVA with FEU NC and the previous systems are described below. The current hardware that generates pressure in the Finapres NOVA contains components which are end-of-life. Therefore, they will need to be replaced. It was decided not to redesign these PCBs, but to redesign the whole pressure control hardware for reasons mentioned below. In the new NOVA with FEU NC, the wrist unit FEU of the current NOVA system is replaced by the wrist unit FEU Nano Core. The FEU Nano Core wrist unit has the capability of generating pressure in the wrist unit, whereas with the FEU wrist unit the pressure was generated in the NOVA base station. This means that the pump, printed circuit boards (PCBs) and FEU have been replaced by a new power supply PCB and the FEU NC. By moving the pressure generation and control to the Nano Core wrist unit, there is no need for a pressure cable from the base station to the wrist unit anymore, which increases the mobility of the system and patient. # 5. Indications for use The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. {5}------------------------------------------------ When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. Using the blood pressure calibration module, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in hospitals, clinics and research centers. {6}------------------------------------------------ ### 6. Comparison of technical characteristics to predicate devices K141460 and K160967 The modified Finapres NOVA with FEU NC has the finapres Nova from submission K141460 and K160967: - Both devices use the same operating principles and use the same algorithms, see Table 3 below. . In summary, the Finapres NOVA with FEU NC described in this submission is, in our opinion, substantially equivalent to the predicate device Finapres NOVA. | Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals. Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. | The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. | The Finapres NOVA with FEU NC is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject's finger. The Finapres NOVA with FEU NC provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA with FEU NC has the option to include five additional modules to extend its functionality with ECG, SpO2, blood pressure calibration and data transfer to and from the device. | Yes, see note 1 below this table. | | Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? | | | When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. | When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. | When the SpO2 module is present, the Finapres NOVA with FEU NC can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. | | | | When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. | When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. | When the ECG module is present, the Finapres NOVA with FEU NC can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. | | | | When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. | When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. | When the blood pressure calibration module is present, the Finapres NOVA with FEU NC can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. | | | | The Finapres NOVA is intended to be used for subjects above 18 years of age. | The Finapres NOVA is intended to be used for subjects above 18 years of age. | The Finapres NOVA with FEU NC is intended to be used for subjects above 18 years of age. | | | | The Finapres NOVA is intended for use in a professional medical environment. | The Finapres NOVA is intended for use in hospitals, clinics and research centers. | The Finapres NOVA is intended for use in hospitals, clinics and research centers, see note 1 below this table. | | | Measurement method / Algorithm | The Finapres NOVA uses the algorithm arterial volume-clamp method of J. Peñáz and the Physiocal criteria (Servo SelfAdjust) of K.H. Wesseling for the continuous measurement of blood pressure | The Finapres NOVA uses the algorithm arterial volume-clamp method of J. Peñáz and the Physiocal criteria (Servo SelfAdjust) of K.H. Wesseling for the continuous measurement of blood pressure | The Finapres NOVA with FEU NC uses the algorithm arterial volume-clamp method of J. Peñáz and the Physiocal criteria (Servo SelfAdjust) of K.H. Wesseling for the continuous measurement of blood pressure | No | | Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? | | | The Finapres NOVA uses the NOVAScope/Modelflow software technology to analyze the trend hemodynamic parameters on the device and main module firmware to control the measurement | The Finapres NOVA uses the NOVAScope/Modelflow software technology to analyze the trend hemodynamic parameters on the device and main module firmware to control the measurement | The Finapres NOVA with FEU NC uses the NOVAScope/Modelflow software technology to analyze the trend hemodynamic parameters on the device. The firmware of the FEU NC controls the measurement | Yes, see note 2 below this table | | Maximum measurement duration | Maximum 24 h continuous measurement | Maximum 24 h continuous measurement | Maximum 24 h continuous measurement | No | | How supplied | Stationary Base station to which subject is connected and to generate pressure | Stationary Base station to which subject is connected and to generate pressure | Stationary Base station to which subject is connected (no pressure generation) | Yes, different materials and design, see note 3 below this table | | | Front-end unit to interface the signals from the electronics and air supply in the main module to the finger cuffs | Front-end unit to interface the signals from the electronics and air supply in the main module to the finger cuffs | Front-end unit to generate air pressure signals to and interpret electronic signals from the finger cuffs. Receives data and power from base station, sends blood pressure data to base station | Yes, different material of the FEU cable and design, see note 3 below this table | | | Finger cuffs for continuous blood pressure measurement | Finger cuffs for continuous blood pressure measurement | Finger cuffs for continuous blood pressure measurement | no | | | Hydrostatic height correction unit compensates for vertical movement of the hand relative to heart level (optional). | Hydrostatic height correction unit compensates for vertical movement of the hand relative to heart level (optional). | Hydrostatic height correction unit compensates for vertical movement of the hand relative to heart level (optional). | no | | | Analog input/output module (optional) | Analog input/output module (optional) | Analog input/output module (optional) | no | | | Upper arm calibration module with arm cuff for pressure calibration (optional) | Upper arm calibration module with arm cuff for pressure calibration (optional) | Upper arm calibration module with arm cuff for pressure calibration | no | | | ECG module with 3 or 5 lead ECG cable (optional) | ECG module with 3 or 5 lead ECG cable (optional) | ECG module with 3 or 5 lead ECG cable (optional) | no | | | SpO2 module with SpO2 finger clip (optional) | SpO2 module with SpO2 finger clip (optional) | SpO2 module with SpO2 finger clip (optional) | no | | Parameter | Finapres NOVA K141460 | Finapres NOVA K160967 | Finapres NOVA with FEU NC | Different? | | | No separate software package for data downloading. Finapres wave form data can be analyzed by the NOVAScope software on the Finapres NOVA. | No separate software package for data downloading. Finapres wave form data can be analyzed by the NOVAScope software on the Finapres NOVA. | No separate software package for data downloading. Finapres wave form data can be analyzed by the NOVAScope software on the Finapres NOVA. | no | | Required accessories |…