A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS

K993888 · A&D Engineering, Inc. · DXN · Dec 20, 1999 · Cardiovascular

Device Facts

• Record ID: K993888
• Device Name: A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.

Device Story

A&D Medical LifeSource UA-779PC and UA-779T are digital blood pressure monitors; utilize oscillometric measurement principle to determine systolic/diastolic blood pressure and pulse rate. Intended for use by adults (18+) in home or clinical settings. Device captures pressure oscillations via cuff; processes signals to derive hemodynamic parameters. Output displayed to user/clinician for monitoring purposes. Supports clinical decision-making regarding hypertension management and cardiovascular health tracking.

Clinical Evidence

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

Technological Characteristics

Oscillometric measurement principle; digital display; cuff-based system. Class II device (Product Code: DXN).

Indications for Use

Indicated for individuals 18 years and older for home or clinical monitoring of systolic/diastolic blood pressure and pulse rate using the oscillometric method.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 1999

A&D Engineering, Inc. c/o Robert Mosenkis CITECH 5200 Butler Pike Plymouth Meeting, PA 19462

кадзава Re : A&D Medical, Models UA-779PC, UA-779T Requlatory Class: II (two) Product Code: DXN November 15, 1999 Dated: Received: November 16, 1999

Dear Mr. Mosenkis:

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, thereforc, 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 requlations 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 Regulation (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 regulatory 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 - Mr. Robert Mosenkis

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,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., Acting 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 (if known): ___ Kココラ888

Device Name: A&D Medical LifeSource UA-779PC & UA-779T Digital Blood Pressure Monitors

Indications for Use:

The A&D Medical LifeSource UA-779PC & UA-779T are designed to be used by end users who are eighteen (18) years and older at home and doctor/nuse office to monitor their blood pressure (systolic and diastolic) and pulse rate. UA-779PC &UA-779T uses the oscillometric method to conduct the measurement.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use QI Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ ×

(Optional Format 1-2-96)

Dele K. Looper le
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Ivision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _ K993888

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