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ATGM MODEL AT-80

by Herald of America, Inc.

510(k) K802191

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 NumberK802191 Date12 Nov 1980ClearedStatusActive

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  • Withdrawn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
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 ATGM MODEL AT-80 is a system for non-invasive blood pressure measurement classified under the DXN product code. It is designed for cardiovascular applications and operates as a medical device for monitoring blood pressure without invasive procedures.

The device is supplied by Herald of America, Inc. and received FDA 510(k) clearance on November 12, 1980, with a decision of Substantially Equivalent. It is a Class II device reviewed by the Cardiovascular panel and is not third-party reviewed. The device is stored according to manufacturer specifications and is intended for single-use or reuse as indicated by the product information.

Questions

AI-generated answers, 23 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 ATGM MODEL AT-80 used for?

    The ATGM MODEL AT-80 is a medical device designed for non-invasive blood pressure measurement in cardiovascular applications. It allows healthcare providers to monitor blood pressure without performing invasive procedures on patients.

  • Is the ATGM MODEL AT-80 a single-use or reusable device?

    The ATGM MODEL AT-80 can be either single-use or reusable as indicated by the product information. The specific usage instructions would be detailed in the manufacturer's documentation that accompanies the device.

  • What regulatory approvals does the ATGM MODEL AT-80 have?

    The ATGM MODEL AT-80 received FDA 510(k) clearance on November 12, 1980, with a decision of Substantially Equivalent. It is classified as a Class II device under the DXN product code and was reviewed by the Cardiovascular panel.

  • How should the ATGM MODEL AT-80 be stored?

    The ATGM MODEL AT-80 should be stored according to the manufacturer's specifications. While specific storage conditions aren't detailed in the provided information, following the manufacturer's guidelines would ensure proper maintenance of the device's functionality.