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Model PM-20A Physiological Monitor

by Advanced Medical Systems, Inc.

510(k) K880756

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 NumberK880756 Date27 Sep 1988ClearedStatusActive

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  • Withdrawn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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Model PM-20A Physiological Monitor is a medical device classified under product code DQA, designed for monitoring cardiovascular parameters. It is intended to measure and display physiological signals such as electrocardiogram (ECG), blood pressure, and heart rate to assess patient vital signs in clinical settings.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K880756) with a traditional review pathway. It was authorized for use in 1988 and falls under the Cardiovascular advisory committee classification, adhering to FDA standards for cardiovascular monitoring equipment.

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