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AMD Home Health Monitoring System

by Advanced Medical Devices, Inc.

510(k) K960337

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960337 Date24 Sep 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AMD Home Health Monitoring System is a noninvasive blood pressure measurement device that provides signals from which systolic, diastolic, and mean pressures can be derived through the use of transducers placed on the surface of the body. This system is designed for home health monitoring applications and includes a monitoring station component. The device is classified as a Class II medical device in the Clinical Chemistry specialty.

The AMD Home Health Monitoring System is supplied by Advanced Medical Devices, Inc. and has received FDA 510(k) clearance with K number K960337. The device is regulated under product code CGA and regulation number 862.1345. It is intended for use in noninvasive blood pressure monitoring in home health settings.

Other devices from Advanced Medical Devices, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the AMD Home Health Monitoring System used for?

    The AMD Home Health Monitoring System is designed for noninvasive blood pressure monitoring in home health settings. It provides signals from which systolic, diastolic, and mean pressures can be derived through transducers placed on the body's surface.

  • How is the AMD Home Health Monitoring System supplied?

    The system is supplied by Advanced Medical Devices, Inc. and includes a monitoring station component. It is classified as a Class II medical device in the Clinical Chemistry specialty and is intended specifically for home health monitoring applications.

  • What is the regulatory status of the AMD Home Health Monitoring System?

    The device has received FDA 510(k) clearance with K number K960337. It is regulated under product code CGA and regulation number 862.1345. The clearance was granted on September 24, 1996, after being received on January 24, 1996.

  • Is the AMD Home Health Monitoring System reusable or single-use?

    The device data does not specify whether the AMD Home Health Monitoring System is reusable or single-use. The system includes a monitoring station component, which suggests it may be designed for repeated use, but this information is not explicitly stated in the provided specifications.