ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K

K060342 · Rossmax International , Ltd. · DXN · Apr 4, 2006 · Cardiovascular

Device Facts

• Record ID: K060342
• Device Name: ROSSMAX AUTOMATIC BLOOD PRESSURE MONITOR MODEL MO701K
• Applicant: Rossmax International , Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Apr 4, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.

Device Story

Rossmax Automatic Blood Pressure Monitor (Model MO701k) is an oscillometric device for home use. It measures systolic/diastolic blood pressure and pulse rate in adults. Device operates via automated cuff inflation/deflation; sensors detect pressure oscillations; internal processor calculates blood pressure and pulse values. Results are displayed on an integrated screen for user review. Intended for patient self-monitoring to assist in tracking cardiovascular health metrics.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Noninvasive oscillometric blood pressure measurement system. Class II device (Product Code: DXN). Operates via automated cuff inflation/deflation and pressure sensing. Designed for home use.

Indications for Use

Indicated for adult individuals for the measurement of systolic blood pressure, diastolic blood pressure, and pulse rate in a home environment.

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

4 2006 APR

Rossmax Inernational Ltd. c/o Mr. Mark C.H. Lin Regulatory Affairs Manager 12 F., No. 189, Kang chien Road Taipei 114

TAIWAN

Re: K060342

Trade Name: Roossmax Automatic Blood Pressure Monitor, Model MO701k Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: February 08, 2006 Received: February 10. 2006

Dear Mr. Lin:

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.

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Page 2 – Mr. Mark C.H. Lin

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,

Blummenthal

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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## 060342

## 2. Statement of Indications for use

## Indications for Use

510(k) Number (if known):

Device Name: Rossmax Automatic Blood Pressure Monitor, Model MO701k

Indications For Use:

Rossmax Automatic Blood Pressure Monitor, Model MO701k is used to measure systolic, diastolic, and pulse rate for adult individual in a home environment.

Prescription Use _______________ AND/OR

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bihmemema
(Division Sign-Off)
Division of Cardiovascular Devices

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