ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II

K053006 · Rossmax Internationl , Ltd. · DXQ · Feb 3, 2006 · Cardiovascular

Device Facts

• Record ID: K053006
• Device Name: ROSSMAX DIGITAL SPHYGMOMANOMETER MANDAUS II
• Applicant: Rossmax Internationl , Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.

Device Story

Digital sphygmomanometer; measures systolic/diastolic blood pressure in adults. Uses auscultatory method via Korotkoff sound detection. Operated by trained medical personnel or trained general users in clinical or home settings. Device processes acoustic signals to determine blood pressure values; displays results for user review. Facilitates blood pressure monitoring for hypertension management or general health assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-invasive digital sphygmomanometer; utilizes auscultatory method for blood pressure measurement; detects Korotkoff sounds; intended for adult use.

Indications for Use

Indicated for non-invasive measurement of systolic and diastolic blood pressure in adults. Suitable for use by trained medical personnel or trained general users.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 3

Rossmax International Ltd c/o Mr. Tzu-Wei Li Center for Measurement Standards Building 16, 321 Kuang Fu Rd,. Sec. 2 Hsinchu, Taiwan 30042, R.O.C.

Re: K053006

Trade Name: Rossmax Digital Sphygmomanometer MANDAUS II Regulation Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ, LDE Dated: January 19, 2006 Received: January 24, 2006

Dear Mr. Li:

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.

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

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Page 2 - Mr. Tzu-Wei Li

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/cdrh/industry/support/index.html.

Sincerely yours,

Bhimnimon 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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## 2. Statement of Indications for use

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K05 3006 510(k) Number:

Rossmax Digital Sphygmomanometer MANDAUS II Device Name:

Indications For Use:

The Rossmax Digital Sphygmomanometer MANDAUS II is a non-invasive medical device intended to measure the systolic, diastolic blood pressure for adults, using the auscultatory method by detecting Korotkoff sound. This device will be used by trained medical and health care personnel or trained general users.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use X

(Optional Format 1-2-96)

Blummmmor
Division Sign-Off
Division of Cardiovascular Devices

STORKI Numb

510(k) submission

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Rossmax International Ltd.