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FDA 510(k)

STARKEY EUROLINE A SERIES

K-Number: K940978 · 1994-05-04

ApplicantStarkey Laboratories, Inc.
Decision Date1994-05-04
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STARKEY EUROLINE A SERIES 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 1994-05-04 under 510(k) number K940978. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STARKEY EUROLINE A SERIES?

STARKEY EUROLINE A SERIES is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K940978.

When did STARKEY EUROLINE A SERIES receive FDA 510(k) clearance?

STARKEY EUROLINE A SERIES received FDA 510(k) clearance on 1994-05-04, under 510(k) number K940978.

Who is the listed applicant for STARKEY EUROLINE A SERIES?

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 STARKEY EUROLINE A SERIES?

The FDA product code for STARKEY EUROLINE A SERIES is ESD.

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Other records listing Starkey Laboratories, Inc. as applicant

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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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