OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL

K052153 · Omron Healthcare, Inc. · DXN · Sep 8, 2005 · Cardiovascular

Device Facts

• Record ID: K052153
• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Device Story

Digital blood pressure monitor; measures blood pressure and pulse rate in adults. Uses oscillometric method to detect pressure oscillations; identifies irregular heartbeats during measurement. Provides warning signal with readings. Intended for home or clinical use; operated by patient or clinician. Output displayed on device screen; assists in monitoring cardiovascular health.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Digital oscillometric blood pressure monitor. Measures systolic/diastolic pressure and pulse rate. Includes irregular heartbeat detection feature. Standalone device; battery or AC powered.

Indications for Use

Indicated for adult patients to measure blood pressure and pulse rate. Detects irregular heartbeats during measurement and provides a warning signal.

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)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circle around the eagle.

SEP - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Omron Healthcare, Inc. c/o Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories Inc. 333 Pfingsten Road Northbrook, IL 60062

Re: K052153

Trade Name: Omron Automatic Blood Pressure Monitor, Model HEM-741CRELN Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 24, 2005 Received: August 25, 2005

Dear Ms. Ankova:

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. 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.

{1}------------------------------------------------

Page 2 – Ms. Silvia Ankova

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc davilsou that I Dr o retain that your device complies with other requirements of the Act that I Drinas Intacted and regulations administered by other Federal agencies. You must or any I each blacked the requirements, including, but not limited to: registration and listing compry with and not 110 110 110 Part 801); good manufacturing practice requirements as set (21 CFR Part 801); asseming (21 CFR Part 820); and if applicable, the electronic rorduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only of to begin marketing your device as described in your Section 510(k) I ms letter will and in your your e FDA finding of substantial equivalence of your device to a legally prematication. The Presults 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 it you attire 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 from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Brimmer for

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

Enclosure

{2}------------------------------------------------

## INDICATION FOR USE STATEMENT

Applicant:

omron healthcare, Inc.

510(k) Number:

K

Device Name:

OMRON Automatic Blood Pressure Monitor, Model: HEM-741CRELN

(OMRON Internal Model Name: HEM-7041-W)

Indication for Use:

The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.

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

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

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)

B. Hammermor

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K 05 215

Page 1 of