Who is the manufacturer of Automatic Upper Arm Blood Pressure Monitor?

Dongguan E-Test Technology Co., Ltd. filed the 510(k) submission for Automatic Upper Arm Blood Pressure Monitor (K193627).

What is the FDA product code for Automatic Upper Arm Blood Pressure 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 Automatic Upper Arm Blood Pressure Monitor?

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

What are the predicate devices for Automatic Upper Arm Blood Pressure Monitor?

AGE Automatic Upper Arm Blood Pressure Monitor (K153552); AGE Automatic Upper Arm Blood Pressure Monitor (K172895).

Who can help prepare an FDA 510(k) submission like Automatic Upper Arm Blood Pressure 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.

Automatic Upper Arm Blood Pressure Monitor

K193627 · Dongguan E-Test Technology Co., Ltd. · DXN · Jul 12, 2020 · Cardiovascular

Device Facts

Record ID	K193627
Device Name	Automatic Upper Arm Blood Pressure Monitor
Applicant	Dongguan E-Test Technology Co., Ltd.
Product Code	DXN · Cardiovascular
Decision Date	Jul 12, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual.

Device Story

Device is an automatic upper arm blood pressure monitor using oscillometric method. Input: cuff pressure changes detected by electronic capacitive pressure sensor. Processing: sensor converts pressure alterations to electrical signals; algorithm analyzes signals to determine systolic/diastolic pressure and pulse rate. Output: digital display of blood pressure, pulse rate, date, time, WHO classification bar, and status icons (low battery, heart). Used in clinical or home settings by patients or medical professionals. Benefits: non-invasive, convenient blood pressure monitoring for hypertension management.

Clinical Evidence

No new clinical data presented. Substantial equivalence is based on identical hardware and software to predicate devices, which were previously demonstrated to conform to AAMI/ANSI/ISO 81060-2 for clinical validation of automated measurement.

Technological Characteristics

Materials: ABS plastic, Nylon, Latex. Sensing: Electronic capacitive pressure sensor. Energy: DC 6V (4 x AA alkaline batteries). Connectivity: Standalone. Software: V01. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, ISO 10993-5/10, ISO 81060-2.

Indications for Use

Indicated for adult patients to monitor and display systolic/diastolic blood pressure and pulse rate using an upper arm cuff. Intended for use by medical professionals or at home.

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

AGE Automatic Upper Arm Blood Pressure Monitor (K153552)
AGE Automatic Upper Arm Blood Pressure Monitor (K172895)

Related Devices

K193624 — Automatic Upper Arm Blood Pressure Monitor · Dongguan E-Test Technology Co., Ltd. · Jul 10, 2020
K070828 — KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR · Kodon(Tianjin)Electronic&Electrical Apparatus Co., · Aug 15, 2007
K102988 — ELECTRONIC BLOOD PRESURE MONITOR · Shenzhen Pango Electronic Co., Ltd. · Nov 9, 2010
K062033 — BP 101 DIGITAL BLOOD PRESSURE MONITOR · Kingyield Hongkong Limited · Mar 23, 2007
K172895 — AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 · Ageless Health Industrial Co., Ltd. · Jun 18, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 12, 2020 Dongguan E-Test Technology Co., LTD % Cassie Lee, Manager Dongguan E-Test Technology Co., Ltd Room 201, 301. Building 1, Changping Section No.1, Dongshen Road Dongguan City, Guangdong, China 523588 Re: K193627 Trade/Device Name: Automatic Upper Arm Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 24, 2019 Received: December 26, 2019 Dear Cassie Lee: 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 {1}------------------------------------------------ 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193627 Device Name Automatic Upper Arm Blood Pressure Monitor Indications for Use (Describe) Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X 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 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. ### 1. Submitter's Information 510(k) Owner's Name: DONGGUAN E-TEST TECHNOLOGY CO., LTD Establishment Registration Number: Applying Address: Room 201,301. Building 1, Changping Section No.1,Dongshen Road, Changping Town, Dongguan City, Guangdong, China. Tel: +86-0769-81158038 Contact Person (including title): Victor Wan (Vice-president) E-mail: victor@agelh.com # Application Correspondent: Contact Person: Ms. Cassie Lee DONGGUAN E-TEST TECHNOLOGY CO., LTD Address: Room 201,301, Building 1, Changping Section No.1, Dongshen Road, Changping Town, Dongguan City, Guangdong, China. Tel: +86-0769-81158038 {4}------------------------------------------------ K193627 Email: requlatory @glomed-info.com # 2. Subject Device Information Type of 510(k): Traditional Common Name: Noninvasive blood pressure measurement systems Classification Name: System, Measurement, Blood-Pressure, Non-Invasive Trade Name: Automatic Upper Arm Blood Pressure Monitor Model Name: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819 Review Panel: Cardiovascular Product Code: DXN Regulation Number: 870.1130 Regulatory Class: 2 # 3. Predicate Device Information | Sponsor | Dongguan Ageless Health Industrial Co., Ltd Dongguan Ageless Health Industrial Co., Ltd | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name and Model | AGE Automatic Upper Arm Blood Pressure Monitor Models: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X AGE Automatic Upper Arm Blood Pressure Monitor Models: BA-815, BA-816, BA-818, BA-819 | {5}------------------------------------------------ | 510(k) Number | K153552 | K172895 | |----------------------|----------|----------| | Product Code | DXN | DXN | | Regulation Number | 870.1130 | 870.1130 | | Regulation Class | II | II | ### 4. Device Description Automatic Upper Arm Blood Pressure Monitor is designed to measure the systolic, diastolic and pulse rate of an individual by using a non-invasive technique which an inflatable cuff is wrapped around upper arm. Our method to define systolic and diastolic pressures is similar to the auscultatory method but using an electronic capacitive pressure sensor rather than stethoscope and mercury manometer. The sensor converts tiny alteration in cuff pressure to electrical signals; by analyzing those signals to define the systolic, diastolic and calculating pulse rate is a well-known technique in the market so called "oscillometric method". The device also has low voltage indication, which will be triggered when the battery is low. #### 5. Intended Use / Indications for Use Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual. {6}------------------------------------------------ ### 6. Test Summary The whole product and manufacturing used for the Automatic Upper Arm Blood Pressure Monitor are identical to those of the predicate device, which were demonstrated to conform with the following standards: - ◆ IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005 + A1:2012 - � IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances -Requirements and tests, 2014 - IEC 60601-1-11, Medical Electrical Equipment Part 1-11: General Requirements for Basic � Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1 (2011)] - � IEC 80601-2-30, Medical Electrical Equipment - Part 2-30: Particular Requirements For The Basic Safety And Essential Performance Of Automated Noninvasive Sphygmomanometers - � ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009 - � ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization, 2010 - AAMI / ANSI / ISO 81060-2 Second Edition, Non-Invasive Sphygmomanometers Part 2: � Clinical Validation of Automated Measurement Type. (Cardiovascular) # 7. Comparison to predicate device and conclusion {7}------------------------------------------------ The technological characteristics, features, specifications, materials, mode of operation, and intended use of Automatic Upper Arm Blood Pressure Monitor is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. | Elements of Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|----| | Company | DONGGUAN E-TEST TECHNOLOGY CO., LTD | Dongguan Ageless Health Industrial Co., Ltd | Dongguan Ageless Health Industrial Co., Ltd | -- | | | Product Name | Automatic Upper Arm Blood Pressure Monitor | AGE Automatic Upper Arm Blood Pressure Monitor | AGE Automatic Upper Arm Blood Pressure Monitor | -- | | | Model Name | BA-801X, BA-802X, BA- 803X, BA-805X, BA- 806X, BA-811X, BA- 812X, BA-813X, BA- 821X, BA-822X, BA- 823X, BA-826X, BA-818, BA-819 | BA-801X, BA-802X, BA- 803X, BA-805X, BA- 806X, BA-811X, BA- 812X, BA-813X, BA- 821X, BA-822X, BA- 823X, BA-826X | BA-815, BA-816, BA-818, BA-819 | -- | | | Classification Name | System, Measurement, Blood-Pressure, Non- Invasive | System, Measurement, Blood-Pressure, Non- Invasive | System, Measurement, Blood-Pressure, Non- Invasive | SE | | | 510(k) Number | K193627 | K153552 | K172895 | -- | | | Product Code | DXN | DXN | DXN | SE | | | Elements of Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | | Intended Use / Indications for Use | Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual. | AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual. | AGE Automatic Upper Arm Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on adult each time, with an air cuff buckled around one's arm according to the instruction in the user's guide manual. | SE | | | Energy source | DC 6V (4 X AA 1.5V alkaline batteries) | DC 6V (4 X AA 1.5V alkaline batteries) | DC 6V (4 X AA 1.5V alkaline batteries) | SE | | | Design | Software | Same version software | | | SE | | | hardware | Same version hardware | | | | | Material | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | ABS plastic, Nylon, Latex | SE | | | Measurement Site | Upper Arm | Upper Arm | Upper Arm | SE | | | Measuring range | Pressure: 0~280 mmHg Pulse: 40~199 beats/minute | Pressure: 0~280 mmHg Pulse: 40~199 beats/minute | Pressure: 0~280 mmHg Pulse: 40~199 beats/minute | SE | | | Pressure resolution | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | 1 mmHg or 0.1kPa | SE | | | Measuring accuracy | Pressure: ± 3mmHg | Pressure: ± 3mmHg | Pressure: ± 3mmHg | SE | | | Elements of Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | | | Pulse: ±5% | Pulse: ±5% | Pulse: ±5% | | | | Cuff Circumference | There are 6 size: size A: 17cm--22cm (SMALL ADULT CUFF) size B: 22cm--30cm (ADULT CUFF-1) size C: 24cm--34cm (ADULT CUFF-2) size D: 22cm--42cm (L- LARGE ADULT CUFF) size E: 30cm--42cm (LARGE ADULT CUFF) size F: 42cm--50cm (EXTRA LARGE ADULT CUFF) | size A: 17cm--22cm (SMALL ADULT CUFF) size B: 22cm--30cm (ADULT CUFF-1) size C: 24cm--34cm (ADULT CUFF-2) size D: 22cm--42cm (L- LARGE ADULT CUFF) size E: 30cm--42cm (LARGE ADULT CUFF) size F: 42cm--50cm (EXTRA LARGE ADULT CUFF) | For BA-815: 22-34 cm; For BA-816: 28-42 cm; For BA-818 and BA-819, there are 6 size: size A: 17cm--22cm (SMALL ADULT CUFF) size B: 22cm--30cm (ADULT CUFF-1) size C: 24cm--34cm (ADULT CUFF-2) size D: 22cm--42cm (L- LARGE ADULT CUFF) size E: 30cm--42cm (LARGE ADULT CUFF) size F: 42cm--50cm (EXTRA LARGE ADULT CUFF) | SE | | | Size and Weight of model BA- 801X | About 460g (not include battery); (L)115.0mm X (D)103.0mm X (H) 67.5mm | About 460g (not include battery); (L)115.0mm X (D)103.0mm X (H) 67.5mm | / | SE | | | Size and Weight of model BA- 802X | About 460g (not include battery); (L)115.0mm X (D)103.0mm X (H) 67.5mm | About 460g (not include battery); (L)115.0mm X (D)103.0mm X (H) 67.5mm | / | SE | | | Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | | Comparison | | | | | | | Size and Weight of model BA- 803X | About 460g (not include battery) (L)119.0mmX (D)100.0mm X (H)63.2mm | About 460g (not include battery) (L)119.0mmX (D)100.0mm X (H)63.2mm | / | SE | | | Size and Weight of model BA- 805X | About 460g (not include battery) (L) 118.3mm X (D)100.0mm X (H)62.9mm | About 460g (not include battery) (L) 118.3mm X (D)100.0mm X (H)62.9mm | / | SE | | | Size and Weight of model BA- 806X | About 460g (not include battery) (L) 146.0mm X (D)113.0mm X (H)66.0mm | About 460g (not include battery) (L) 146.0mm X (D)113.0mm X (H)66.0mm | / | SE | | | Size and Weight of model BA- 811X | About 460g (not include battery) (L) 144.0mm X (D)113.0mm X (H)67.0mm | About 460g (not include battery) (L) 144.0mm X (D)113.0mm X (H)67.0mm | / | SE | | | Size and Weight of model BA- 812X | About 460g (not include battery) (L) 113.5mm X (D)92.0mm X (H)48.0mm | About 460g (not include battery) (L) 113.5mm X (D)92.0mm X (H)48.0mm | / | SE | | | Size and Weight of model BA- 813X | About 460g (not include battery) (L) 115.3mm X (D)92.0mm X (H)48.0mm | About 460g (not include battery) (L) 115.3mm X (D)92.0mm X (H)48.0mm | / | SE | | | Elements of Comparison | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | | | | | | | | | Size and Weight of model BA- 821X | About 610g (not include battery) (L) 150.0mm X (D)100.0mm X (H)60.0mm | About 610g (not include battery) (L) 150.0mm X (D)100.0mm X (H)60.0mm | / | SE | | | Size and Weight of model BA- 822X | About 380g (not include battery) (L) 135.0mm X (D)90.0mm X (H)47.65mm | About 380g (not include battery) (L) 135.0mm X (D)90.0mm X (H)47.65mm | / | SE | | | Size and Weight of model BA- 823X | About 460g (not include battery) 138.0mm X(D)95.0mm X (H)67.0mm | About 460g (not include battery) 138.0mm X (D)95.0mm X (H)67.0mm | / | SE | | | Size and Weight of model BA- 826X | About 420g (not include battery) 143.0mm X(D)115.0mm X (H)57.0mm | About 420g (not include battery) 143.0mm X (D)115.0mm X (H)57.0mm | / | SE | | | Size and Weight of model BA-818 | About 465g (not include battery) (L) 103.0mm X (D)129.0mm X (H)161.0mm | / | About 465g (not include battery) (L) 103.0mm X (D)129.0mm X (H)161.0mm | SE | | | Size and Weight of model BA-819 | About 438g (not include battery) (L) 160.0mm X (D)98.0mm X (H)55.0mm | / | About 438g (not include battery) (L) 160.0mm X (D)98.0mm X (H)55.0mm | SE | | | Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | | Comparison | | | | | | | Inflation and Deflation | Automatic | Automatic | Automatic | SE | | | Measuring Method | Oscillometry | Oscillometry | Oscillometry | SE | | | Patient Population | Adult | Adult | Adult | SE | | | Display | Blood Pressure (Systolic and Diastolic), Pulse, Date, Time, WHO BP Classification Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number | Blood Pressure (Systolic and Diastolic), Pulse, Date, Time, WHO BP Classification Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number | Blood Pressure (Systolic and Diastolic), Pulse, Date, Time, WHO BP Classification Indicating Bar, Low Battery Icon, Heart Icon, Memory Record Number | SE | | | Software Version | V01 | V01 | V01 | SE | | | Operation condition | Temperature: 5°C ~ 40°C Humidity: 15~90%RH Atmospheric Pressure:86 kPa~106 kPa | Temperature: 5°C ~ 40°C Humidity: 15~90%RH Atmospheric Pressure:86 kPa~106 kPa | Temperature: 5°C ~ 40°C Humidity: 15~90%RH Atmospheric Pressure:86 kPa~106 kPa | SE | | | Transport/stora ge environment | Temperature: -20°C ~ +65°C Humidity: 10~95%RH Atmospheric Pressure:86 kPa~106 kPa | Temperature: -20°C ~ +65°C Humidity: 10~95%RH Atmospheric Pressure:86 kPa~106 kPa | Temperature: -20°C ~ +65°C Humidity: 10~95%RH Atmospheric Pressure:86 kPa~106 kPa | SE | | | Safety | IEC 60601-1 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-11 | IEC 60601-1 IEC 60601-1-11 | SE | | | Elements of | Subject Device | Predicate Device1 | Predicate Device2 | Verdict | | | Comparison | | | | | | | | IEC 80601-2-30 | IEC 80601-2-30 | IEC 80601-2-30 | | | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE | | | Biocompatibility | ISO 10993 series | ISO 10993 series | ISO 10993 series | SE | | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ {13}------------------------------------------------ # Comparison in Detail(s): # Final Conclusion: The subject device noninvasive sphygmomanometer (Automatic Upper Arm Blood Pressure Monitor) (Model: BA-801X, BA-802X, BA-803X, BA-805X, BA-806X, BA-811X, BA-812X, BA-813X, BA-821X, BA-822X, BA-823X, BA-826X, BA-818, BA-819) has all features of the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device. All hardware and software of the subject device are based on that of the predicate device K 153552 and K 172895 since no new testing is presented in the submission. 8. Date of the summary prepared: July 8, 2020