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FDA 510(k)

ATGM MODEL AT-80

K-Number: K802191 · 1980-11-12

ApplicantHerald of America, Inc.
Decision Date1980-11-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATGM MODEL AT-80 is the device name listed in this FDA 510(k) record. The listed applicant is Herald of America, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802191. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATGM MODEL AT-80?

ATGM MODEL AT-80 is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Herald of America, Inc.. The 510(k) number is K802191.

When did ATGM MODEL AT-80 receive FDA 510(k) clearance?

ATGM MODEL AT-80 received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802191.

Who is the listed applicant for ATGM MODEL AT-80?

The FDA 510(k) record lists Herald of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATGM MODEL AT-80?

The FDA product code for ATGM MODEL AT-80 is DXN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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