Who is the manufacturer of QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

Quanta Computer, Inc. filed the 510(k) submission for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 (K083078).

What is the FDA product code for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

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

What is the regulatory pathway for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

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

What are the predicate devices for QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

OMRON Automatic Blood Pressure Monitor, Model HEM-711AC (K052154); A&D LifeSource Automatic Blood Pressure Monitor, Model UA-767 (K982481).

Who can help prepare an FDA 510(k) submission like QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200?

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.

QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200

K083078 · Quanta Computer, Inc. · DXN · Nov 26, 2008 · Cardiovascular

Device Facts

Record ID	K083078
Device Name	QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200
Applicant	Quanta Computer, Inc.
Product Code	DXN · Cardiovascular
Decision Date	Nov 26, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population.

Device Story

Non-invasive blood pressure monitor; uses oscillometric method to determine systolic/diastolic blood pressure and pulse rate. Input: pressure oscillations detected via upper arm cuff inflated by electrical air pump. Operation: cuff inflation followed by controlled deflation via preset mechanical valve; device processes pressure signals to calculate blood pressure and pulse. Output: measurement results displayed on LCD. Intended for adult patient population; used in clinical or home settings. Provides objective blood pressure data to assist healthcare providers or users in monitoring cardiovascular status.

Clinical Evidence

Bench testing only. Device conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2 standards.

Technological Characteristics

Oscillometric measurement principle; electrical air pump; preset mechanical valve for deflation; LCD display. Conforms to EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2.

Indications for Use

Indicated for adult patients to measure systolic and diastolic blood pressure and pulse rate via oscillometric method using an upper arm cuff.

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

OMRON Automatic Blood Pressure Monitor, Model HEM-711AC (K052154)
A&D LifeSource Automatic Blood Pressure Monitor, Model UA-767 (K982481)

Related Devices

K221913 — Arm Blood Pressure Monitor · Alicn Medical Shenzhen, Inc. · Oct 12, 2022
K230642 — Electronic Blood Pressure Monitor · Dongguan Kangweile Electronic Technology Co., Ltd. · Aug 11, 2023
K083395 — SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 · Andon Health Co, Ltd. · Feb 27, 2009
K081159 — HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES · Harvard Medical Devices , Ltd. · Aug 8, 2008
K083681 — BIOLAND BLOOD PRESSURE MONITOR · Bioland Technology, Ltd. · Jan 16, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ #### 510(K) SUMMARY NOV 2 6 2008 K083078 R/ / 2 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92 | 1. Submitter's Name: | Quanta Computer Inc. BG1 Medical Devices Department | | | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Address: | 2F, No. 188, Wen Hwa 2nd Rd., Kuei Shan Hsiang, Tao Yuan Shien 33377, TAIWAN | | | | Phone: | +886-3-327-2345 #18029 | | | | Fax: | +886-3-327-2345 | | | | Contact: | Jason Hung / Title: Specialist 1 | | | | 2. Device Name : | | | | | Trade Name: | Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200 ) | | | | Common Name: | Non-Invasive Blood Pressure Monitor | | | | Classification name | System , Measurement , Blood-Pressure , Non-Invasive | | | | 3. DEVICE CLASS | The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) has been classified as | | | | | Regulatory Class: II | | | | | Panel: 74 | | | | | Product Code: DXN | | | | | Regulation Number: 2ICFR 870.1130 | | | | 4. Predicate Device: | • OMRON Automatic Blood Pressure Monitor, Model HEM-711AC (K052154) marketed by Omron Healthcare, Inc.. | | | | | • A&D LifeSource Automatic Blood Pressure Monitor , Model#UA-767 (K982481) marketed by A & D ENGINEERING, INC.. | | | | 5. Intended Use: | The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population. | | | | | Product: Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) | | | | 6. Device Description: | The Quanta Blood Pressure Meter, Model no.: Cardiac Elite 1000 (or QH200) is designed to measure the systolic and diastolic blood pressure, and pulse rate (heart of an individual). | | | | | The device uses an inflated cuff which is wrapped around the upper arm. The cuff is inflated by an electrical air pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by a preset mechanical valve at a constant rate. At any moment of measurement, the user can deflate the cuff. The measurement results are displayed on the LCD. | | | | 7. Performance Summary: | In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included EN-1060-1, EN-1060-3, ANSI/AAMI SP-10, IEC | | | Page 1 of 2 Section 4 - 510(k) Summary REV. [A] {1}------------------------------------------------ 60601-1 and IEC 60601-1-2 requirements. 083079 ### 8. Conclusions: The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) has the same intended use and similar technological characteristics as the OMRON Automatic Blood Pressure Monitor, Model HEM-711AC (K052154) marketed by Omron Healthcare, Inc., and A&D LifeSource Automatic Blood Pressure Monitor , Model#UA-767 (K982481) marketed by A & D ENGINEERING, INC.. Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is substantially equivalent to the predicate devices. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a caduceus, a symbol often associated with healthcare, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 2 6 2008 Quanta Computer Inc. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive Flagstaff, AZ 86001 Re: K083078 Trade/Device Name: Quanta Blood Pressure Meter, Cardiac Elite 1000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 13, 2008 Received: October 16, 2008 Dear Ms. Reich: 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 intenstate 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 1 11The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your devire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, RDAouv 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 complics with other requirements aft the Act {3}------------------------------------------------ #### Page 2 - Ms. Jennifer Reich 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: registres. - Tournalisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000. This letter will allow you to begin marketing your device as described in your Section 5.10(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, permits your device - to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at(240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of devices adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Arth the Division of Small Manufacturers, International and Consumer Assistance an its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html. Sincerely yours, [signature] O Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): 长oß3078 Device Name: Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) Quanta Computer Inc. BG1 Medical Devices Department Indications For Use: The Quanta Blood Pressure Meter , Model no.: Cardiac Elite 1000 (or QH200) is intended to measure the blood pressure (systolic and diastolic) and pulse rate by oscillometric method. The measurements are conducted by using an cuff which is wrapped around the upper arm. The device is designed for adult patient population. | Prescription Use (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use (21 CFR 807 Subpart C) | V | |-------------------------------------------------|--------|------------------------------------------------|---| |-------------------------------------------------|--------|------------------------------------------------|---| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |------------------------------------|---------| | Division of Cardiovascular Devices | | | 510(k) Number | K083078 | Page 1 of 1