OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M

K042506 · Omron Healthcare, Inc. · DXN · Apr 5, 2005 · Cardiovascular

Device Facts

• Record ID: K042506
• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
• 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 arm circumference ranging from 9 inches to 17 inches (22 cm to 42 cm). 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 via oscillometric method; intended for adult use; arm circumference 22-42 cm; detects irregular heartbeats during measurement; provides warning signal with readings; used in home or clinical settings; provides objective data for patient monitoring; aids in hypertension management.

Clinical Evidence

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

Technological Characteristics

Digital oscillometric blood pressure monitor; non-invasive; intended for adult use; arm cuff for 22-42 cm circumference; electronic display; battery or AC powered; software-based irregular heartbeat detection.

Indications for Use

Indicated for blood pressure and pulse rate measurement in adults with arm circumferences 22-42 cm. Detects irregular heartbeats.

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

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Public Health Service

APR - 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042506

K042300
Trade Name: OMRON Automatic Blood Pressure Monitor HEM-780N 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 indication We have reviewed your Section 910(tr) premained 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 encrosule, to regally manatise of the Medical Device American walls of the local Food. Drug commerce prior to May 28, 1770, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA devices that have been reclassified in accordance what approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval one of and Cosment Act (Act) that to not require approvial of the general controls provisions of the Act. The You may, therefore, market the device, belower to the more of the may be and general Controls provisions of the rice, 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 i If your device is classifica (sec above) me exist ones a comments of except of the can
may be subject to such additional controls. Existing major regulations FDA mov may be subject to such additional controller stations, "Parts 800 to 898. In addition, FDA may be found in the Code of Pouchal Ingerning 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 teast of advised that I Drissantes cour device complies with other requirements of the Act that I DTT has Intact a actions administered by other Federal agencies. You must of any I cochar sundres and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybelins (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastiation control pro receins (sice as described in your Section 510(k) I mis letter will and in your he FDA finding of substantial equivalence of your device to a legally premailer notification: "The PDF and sification 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 for Jour 2011) 276-0120. Also, please note the regulation entitled, Connact the Orthou of Commarket 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/dsma/dsmamain.html

Sincerely yours,

Blumuma 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

K042506 510(k) Number:

Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N

Indications For 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 9 inches to 17 inches (22 cm to 42 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

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)

Blumman

(Division Sign-Off) (Division of Cardlovascular Devices 510(K) Number_KO40504

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