ANEROID SPHYGMOMANOMETER

K990638 · Genmed, Inc. · DXN · Oct 7, 1999 · Cardiovascular

Device Facts

• Record ID: K990638
• Device Name: ANEROID SPHYGMOMANOMETER
• Applicant: Genmed, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 7, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

These devices are intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Knorokoff sounds. This device is indicated for use by medical personnel or for home use.

Device Story

Genmed Aneroid Sphygmomanometer is a manual blood pressure measurement device. Operation involves manual inflation of a cuff attached to the patient; user listens for Korotkoff sounds to determine systolic and diastolic pressure. Used by medical personnel in clinical settings or by patients for home monitoring. Device provides no automated processing; relies entirely on user skill for auscultatory measurement. Benefits include non-invasive, portable blood pressure assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual aneroid sphygmomanometer; mechanical inflation system; auscultatory measurement principle. No software, electronics, or energy source.

Indications for Use

Indicated for measurement of systolic and diastolic blood pressure in adults by medical professionals or for home use.

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

ОСТ 7 1999

Leonard Frier, P.E. MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230-3432

Re: K990638/S2 Genmed Aneroid Sphygmomanometer Requlatory Class: II (two) Product Code: DXN Dated: July 29, 1999 Received: August 2, 1999

Dear Mr. Frier:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Leonard Frier, P.E.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) NUMBER: K990638

## DEVICE NAME: Genmed Aneroid Sphygmomanometer

## INDICATIONS FOR USE STATEMENT:

These devices are intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Knorokoff sounds. This device is indicated for use by medical personnel or for home use.

Pre scription

Bore R. Kemperle

-1011sion > Cardiovascular, Respiratory, ogical Devi 510(k) Nomber_