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FDA 510(k)

FEDELITY F495, VIENNATONE ALPP II

K-Number: K943687 · 1994-10-20

ApplicantStarkey Laboratories, Inc.
Decision Date1994-10-20
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FEDELITY F495, VIENNATONE ALPP II 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 1994-10-20 under 510(k) number K943687. 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 FEDELITY F495, VIENNATONE ALPP II?

FEDELITY F495, VIENNATONE ALPP II is a medical device that received FDA 510(k) clearance on 1994-10-20. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K943687.

When did FEDELITY F495, VIENNATONE ALPP II receive FDA 510(k) clearance?

FEDELITY F495, VIENNATONE ALPP II received FDA 510(k) clearance on 1994-10-20, under 510(k) number K943687.

Who is the listed applicant for FEDELITY F495, VIENNATONE ALPP II?

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 FEDELITY F495, VIENNATONE ALPP II?

The FDA product code for FEDELITY F495, VIENNATONE ALPP II is ESD.

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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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