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FDA 510(k)

MICROSCREEN I HEARING TESTER

K-Number: K863979 · 1986-11-18

ApplicantMicroscreen
Decision Date1986-11-18
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICROSCREEN I HEARING TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Microscreen. It received FDA 510(k) clearance on 1986-11-18 under 510(k) number K863979. 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 MICROSCREEN I HEARING TESTER?

MICROSCREEN I HEARING TESTER is a medical device that received FDA 510(k) clearance on 1986-11-18. The listed applicant is Microscreen. The 510(k) number is K863979.

When did MICROSCREEN I HEARING TESTER receive FDA 510(k) clearance?

MICROSCREEN I HEARING TESTER received FDA 510(k) clearance on 1986-11-18, under 510(k) number K863979.

Who is the listed applicant for MICROSCREEN I HEARING TESTER?

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

What is the FDA product code for MICROSCREEN I HEARING TESTER?

The FDA product code for MICROSCREEN I HEARING 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.

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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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