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FDA 510(k)

BERCHTOLD ELEKTROTOM 106 HITT

K-Number: K013668 · 2002-02-04

Decision Date2002-02-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BERCHTOLD ELEKTROTOM 106 HITT is the device name listed in this FDA 510(k) record. The listed applicant is Berchtold Corp.. It received FDA 510(k) clearance on 2002-02-04 under 510(k) number K013668. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERCHTOLD ELEKTROTOM 106 HITT?

BERCHTOLD ELEKTROTOM 106 HITT is a medical device that received FDA 510(k) clearance on 2002-02-04. The listed applicant is Berchtold Corp.. The 510(k) number is K013668.

When did BERCHTOLD ELEKTROTOM 106 HITT receive FDA 510(k) clearance?

BERCHTOLD ELEKTROTOM 106 HITT received FDA 510(k) clearance on 2002-02-04, under 510(k) number K013668.

Who is the listed applicant for BERCHTOLD ELEKTROTOM 106 HITT?

The FDA 510(k) record lists Berchtold Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BERCHTOLD ELEKTROTOM 106 HITT?

The FDA product code for BERCHTOLD ELEKTROTOM 106 HITT is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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