OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906

K043018 · Omron Healthcare, Inc. · DXN · Nov 10, 2004 · Cardiovascular

Device Facts

• Record ID: K043018
• Device Name: OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 8 inches to 13 inches (20 cm 33 cm).

Device Story

Omron HEM-906 is an oscillometric digital blood pressure monitor; intended for clinical or home use. Device uses an inflatable cuff to detect arterial pressure oscillations; processes signals to calculate systolic/diastolic blood pressure and pulse rate. Output displayed on integrated screen for user review. Provides non-invasive monitoring to assist healthcare providers or patients in tracking cardiovascular metrics; aids in hypertension management and general health assessment.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on regulatory classification and device description.

Technological Characteristics

Oscillometric measurement principle; digital display; cuff-based system for arm circumferences 20-33 cm. Class II device (21 CFR 870.1130).

Indications for Use

Indicated for measuring blood pressure and pulse rate in adult patients with arm circumferences between 8 and 13 inches (20-33 cm).

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.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2004

Omron Healthcare, Inc. c/o Mr. Larry Lepley Manager, Regulatory/Clinical Affairs 1200 Lakeside Drive Bannockburn, IL 60015-1243

Re: K043018

Trade Name: Omron Healthcare, Inc. Model HEM-906 Oscillometric Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: November 01, 2004 Received: November 02, 2004

Dear Mr. Lepley:

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 10 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. 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.

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 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.

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Page 2 - Mr. Larry Lepley

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blummerfor
R. Zukerman, M.D.

ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## OMRON

## Indications for Use Statement

| 510(k) Number | K043018 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OMRON<br>DIGITAL BLOOD PRESSURE MONITOR<br>MODEL: HEM-906 |
| Indication for Use | The device is a digital monitor intended for use in measuring<br>blood pressure and pulse rate in adult patient population with<br>arm circumference ranging from 8 inches to 13 inches (20 cm<br>33 cm). |

AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use __ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummoor
19

(Division Sign-Off) (Division of Cardiovascular Devices
Division of Cardiovascular Devices 510(k) Number