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FDA 510(k)

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER

K-Number: K902068 · 1990-08-06

ApplicantStarkey Laboratories, Inc.
Decision Date1990-08-06
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 1990-08-06 under 510(k) number K902068. 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 HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER?

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1990-08-06. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K902068.

When did HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER receive FDA 510(k) clearance?

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER received FDA 510(k) clearance on 1990-08-06, under 510(k) number K902068.

Who is the listed applicant for HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER?

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

What is the FDA product code for HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER?

The FDA product code for HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER is EWO.

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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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