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FDA 510(k)

ACOH WELLNESS TESTER

K-Number: K823554 · 1983-01-05

ApplicantOccupational Health, Inc.
Decision Date1983-01-05
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACOH WELLNESS TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Occupational Health, Inc.. It received FDA 510(k) clearance on 1983-01-05 under 510(k) number K823554. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACOH WELLNESS TESTER?

ACOH WELLNESS TESTER is a medical device that received FDA 510(k) clearance on 1983-01-05. The listed applicant is Occupational Health, Inc.. The 510(k) number is K823554.

When did ACOH WELLNESS TESTER receive FDA 510(k) clearance?

ACOH WELLNESS TESTER received FDA 510(k) clearance on 1983-01-05, under 510(k) number K823554.

Who is the listed applicant for ACOH WELLNESS TESTER?

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

What is the FDA product code for ACOH WELLNESS TESTER?

The FDA product code for ACOH WELLNESS TESTER is EWO.

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Related Devices (Code: EWO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

Official Source

View on FDA Database →

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

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