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FDA 510(k)

INTRA S, INTRA SH

K-Number: K941635 · 1994-05-04

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

Device Summary

INTRA S, INTRA SH 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 K941635. 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 INTRA S, INTRA SH?

INTRA S, INTRA SH 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 K941635.

When did INTRA S, INTRA SH receive FDA 510(k) clearance?

INTRA S, INTRA SH received FDA 510(k) clearance on 1994-05-04, under 510(k) number K941635.

Who is the listed applicant for INTRA S, INTRA SH?

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 INTRA S, INTRA SH?

The FDA product code for INTRA S, INTRA SH 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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