BLOOD PRESSURE METER, MODEL CH-311B

K061161 · Citizen Watch Co., Ltd. · DXN · Jun 26, 2006 · Cardiovascular

Device Facts

• Record ID: K061161
• Device Name: BLOOD PRESSURE METER, MODEL CH-311B
• Applicant: Citizen Watch Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jun 26, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Device Story

Blood Pressure Monitor Model CH-311B; oscillometric measurement device for home use. Input: pressure signals via cuff inflation/deflation. Processing: automated calculation of systolic/diastolic blood pressure and pulse rate. Output: digital display of measurements. Operated by patient for personal health tracking. Benefit: enables convenient, non-invasive self-monitoring of cardiovascular parameters outside clinical settings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Oscillometric measurement principle; non-invasive blood pressure monitor; intended for home use; digital display output.

Indications for Use

Indicated for personal health monitoring of systolic/diastolic blood pressure and pulse rate in a home setting. Intended for over-the-counter sale; not for use under direct physician order.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2006

Citizen Watch Co., Ltd c/o Nathan A. Beaver Attorney Foley & Larder 3000 K. Street, NW, Suite 500 Washington DC 20007

Re: K061161

Trade Name: Blood Pressure Monitor, Model CH-311B Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: June 14, 2006 Received: June 15. 2006

Dear Mr. Beaver:

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. Iisting 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. Nathan A. Beaver

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 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/cdrl/industry/support/index.html.

Sincerely yours,

D. Permuta 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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Image /page/2/Picture/0 description: The image shows the word "CITIZEN" in large, bold, sans-serif font. Below the word "CITIZEN" is a black bar with the words "Micro HumanTech" in a smaller font. The words "Micro HumanTech" are white and appear to be in a sans-serif font as well.

## CITIZEN WATCH CO., LTD.

6-1-12, Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, Japan Tel : [phone] Fax : +B1-424-68-4644

Date : June 14, 2006

## Indications for Use

KOGITE I 510(k) Number (if known):

Device Name: Model CH-311B Blood Pressure Meter

Indications For Use: Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Prescription Use _

AND/OR

Over-The-Counter Use

er Use 8

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (ODE)

Bluminia

llovascular Devices