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FDA 510(k)

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229

K-Number: K935701 · 1994-05-10

ApplicantStarkey Laboratories, Inc.
Decision Date1994-05-10
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 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 1994-05-10 under 510(k) number K935701. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229?

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 is a medical device that received FDA 510(k) clearance on 1994-05-10. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K935701.

When did VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 receive FDA 510(k) clearance?

VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 received FDA 510(k) clearance on 1994-05-10, under 510(k) number K935701.

Who is the listed applicant for VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229?

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 VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229?

The FDA product code for VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 is LXB.

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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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