A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR

K982481 · A&D Engineering, Inc. · DXN · Sep 25, 1998 · Cardiovascular

Device Facts

• Record ID: K982481
• Device Name: A&D MEDICAL UA-767PC DIGITAL BLOOD PRESSURE MONITOR
• Applicant: A&D Engineering, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctoring office to montor their blood pressure (systolic and diastolic and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-767PC through its communication port can also transfer the measurements stored in nemory to other electronic devices, such as a PC, a modem, or a printer. The end user should not have common arthythmias, such as atrial or ventricular the measurement It is not designed for sul the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

Device Story

UA-767PC is a digital blood pressure monitor for home or clinical use by adults. Device measures systolic/diastolic blood pressure and pulse rate; stores results in internal memory. Features communication port for data transfer to external devices (PC, modem, printer). Operated by end-user or clinician. Not intended for ambulatory monitoring or patients with common arrhythmias. Provides objective blood pressure data to assist in health monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital blood pressure monitor; oscillometric measurement principle; includes internal memory and communication port for data output; arm cuff accommodates 13.0-45.0 cm circumference.

Indications for Use

Indicated for adults 18+ years for home or clinical monitoring of systolic/diastolic blood pressure and pulse rate. Contraindicated for individuals with common arrhythmias (e.g., atrial or ventricular). Not for ambulatory use. Arm circumference: 13.0 cm to 45.0 cm.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1999

A&D Engineering, Inc. c/o Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

K982481 Re: A&D Medical UA-767PC Digital Blood Pressure Monitor Regulatory Class: II (Two) Product Code: DXN Dated: September 11, 1998 Received: September 14, 1998

Dear Mr. Mosenkis:

This letter corrects our substantially equivalent letter of This letter corrects our baserantially equivalent letter September 25, 1998 and our carding the indications for use statement.

We have reviewed your Section 510(k) notification of intent to market We nave review your above and we have determined the device is the device released [(for the indications for use stated in the SubScancearly by arketed 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 Medical Bevice iment provisions of the Federal Food, Drug, and Cosmetic accordance with blog processore, market the device, subject to the nee (neeronment provisions of the Act. The general controls general concrolo pact include requirements for annual registration, provisions of the nee od manufacturing practice, labeling, and probibitions against misbranding and adulteration.

li your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such echibit) of birds. Existing major regulations affecting your device ann be tound in the Code of Federal Regulations, Title 21, Parts 800 ean be rou substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements

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Page 2 - Mr. Robert Mosenkis

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.

This letter will allow you to continue 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: UA-767PC Digital Blood Pressure Monitor

## Indications for Use:

The UA-767PC is designed to be used by end users who are eighteen (18) years and older at home and doctoring office to montor their blood pressure (systolic and diastolic and pulse rate. At the end of each measurement, the results will be stored in the UA-767PC memory. UA-767PC through its communication port can also transfer the measurements stored in nemory to other electronic devices, such as a PC, a modem, or a printer. The end user should not have common arthythmias, such as atrial or ventricular the measurement It is not designed for sul the measurement. It is not designed for ambulatory use. The arm circumference range shall be between 5.1 inches (13.0 cm) to 17.7 inches (45.0 cm).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K982481 |

| Prescription Use | |
|------------------|--|
|------------------|--|

or

| Over-The-Counter Use | ✓ |
|----------------------|---|
|----------------------|---|

(Optional Format 1-2-96)510(K) 7-1/JW