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FDA 510(k)

AUDIOMETRIC TESTING SYS., SERIES 500

K-Number: K770823 · 1977-05-18

ApplicantAutomated Testing Services, Ltd.
Decision Date1977-05-18
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETRIC TESTING SYS., SERIES 500 is the device name listed in this FDA 510(k) record. The listed applicant is Automated Testing Services, Ltd.. It received FDA 510(k) clearance on 1977-05-18 under 510(k) number K770823. 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 AUDIOMETRIC TESTING SYS., SERIES 500?

AUDIOMETRIC TESTING SYS., SERIES 500 is a medical device that received FDA 510(k) clearance on 1977-05-18. The listed applicant is Automated Testing Services, Ltd.. The 510(k) number is K770823.

When did AUDIOMETRIC TESTING SYS., SERIES 500 receive FDA 510(k) clearance?

AUDIOMETRIC TESTING SYS., SERIES 500 received FDA 510(k) clearance on 1977-05-18, under 510(k) number K770823.

Who is the listed applicant for AUDIOMETRIC TESTING SYS., SERIES 500?

The FDA 510(k) record lists Automated Testing Services, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIOMETRIC TESTING SYS., SERIES 500?

The FDA product code for AUDIOMETRIC TESTING SYS., SERIES 500 is EWO.

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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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