OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N

K042505 · Omron Healthcare, Inc. · DXN · Apr 5, 2005 · Cardiovascular

Device Facts

• Record ID: K042505
• Device Name: OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Story

Digital wrist blood pressure monitor; measures blood pressure and pulse rate via oscillometric method. Intended for over-the-counter use by adult patients. Device wraps around wrist; inflates cuff to detect arterial pressure oscillations; processes signals to determine systolic/diastolic pressure and pulse rate. Includes irregular heartbeat detection feature; provides warning signal if arrhythmia detected during measurement. Output displayed on integrated screen for user review. Facilitates home monitoring of cardiovascular health.

Clinical Evidence

Bench testing only.

Technological Characteristics

Oscillometric measurement principle; digital display; wrist-worn cuff; battery-powered; irregular heartbeat detection algorithm.

Indications for Use

Indicated for adult patients with wrist circumferences between 13.5 cm and 21.5 cm for the measurement of blood pressure and pulse rate. Includes irregular heartbeat detection.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 2005

Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 1200 Lakeside Drive Bannockburn, IL 60015

Re: K042505

Trade Name: OMRON DIGITAL Wrist Blood Pressure Monitor HEM-609N Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 7, 2005 Received: February 8, 2005

Dear Mr. Kojima:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally to regally the Medical Device American procession in the commerce proof to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, therefore, manov of the Act include requirements for annual registration, listing of general controls provisions of the line, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 abor 0) ins existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FDA may oc subject to suell additions, Title 21, Parts 800 to 898. In addition, ITDA may be found in the Obat in the Obacerning your device in the Federal Register.

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Page 2 – Mr. Iwao Kojima

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Dri i losaantes syour device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must of any I cacial statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); adoning (21 CFR Part 820); and if applicable, the electronic form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product lauditori control provisions (sevice as described in your Section 510(k) This icitel will anow you to begin maing of substantial equivalence of your device to a legally prematication. The Pice 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 If you desire specific advice 101-704-2011) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misoralianing of reference to presensibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Bzimmerma for

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

Enclosure

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## Indications for Use

K042505 510(k) Number:

OMRON Device Name: DIGITAL WRIST BLOOD PRESSURE MONITOR MODEL: HEM-609N

Indications For Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).

The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blammana

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(Division Sign-Off) Division of Cardioyascular Devices 510(k) Number 042505