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FDA 510(k)

DESKREM-1000

K-Number: K943459 · 1994-10-21

ApplicantStarkey Laboratories, Inc.
Decision Date1994-10-21
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DESKREM-1000 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 1994-10-21 under 510(k) number K943459. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DESKREM-1000?

DESKREM-1000 is a medical device that received FDA 510(k) clearance on 1994-10-21. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K943459.

When did DESKREM-1000 receive FDA 510(k) clearance?

DESKREM-1000 received FDA 510(k) clearance on 1994-10-21, under 510(k) number K943459.

Who is the listed applicant for DESKREM-1000?

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 DESKREM-1000?

The FDA product code for DESKREM-1000 is ETW.

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Other records listing Starkey Laboratories, Inc. as applicant

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Related Devices (Code: ETW)

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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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