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FDA 510(k)

DEGOTZEN SYNCHRO

K-Number: K021245 · 2002-05-03

ApplicantThe Gotzen Group, Inc.
Decision Date2002-05-03
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEGOTZEN SYNCHRO is the device name listed in this FDA 510(k) record. The listed applicant is The Gotzen Group, Inc.. It received FDA 510(k) clearance on 2002-05-03 under 510(k) number K021245. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEGOTZEN SYNCHRO?

DEGOTZEN SYNCHRO is a medical device that received FDA 510(k) clearance on 2002-05-03. The listed applicant is The Gotzen Group, Inc.. The 510(k) number is K021245.

When did DEGOTZEN SYNCHRO receive FDA 510(k) clearance?

DEGOTZEN SYNCHRO received FDA 510(k) clearance on 2002-05-03, under 510(k) number K021245.

Who is the listed applicant for DEGOTZEN SYNCHRO?

The FDA 510(k) record lists The Gotzen Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEGOTZEN SYNCHRO?

The FDA product code for DEGOTZEN SYNCHRO is EHD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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