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FDA 510(k)

CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7

K-Number: K880334 · 1988-03-18

ApplicantStarkey Laboratories, Inc.
Decision Date1988-03-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 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 1988-03-18 under 510(k) number K880334. 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 CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7?

CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 is a medical device that received FDA 510(k) clearance on 1988-03-18. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K880334.

When did CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 receive FDA 510(k) clearance?

CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 received FDA 510(k) clearance on 1988-03-18, under 510(k) number K880334.

Who is the listed applicant for CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7?

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 CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7?

The FDA product code for CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7 is ESD.

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Related Devices (Code: 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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