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FDA 510(k)

DORNIER THERMAFOCUS 360 FIBER

K-Number: K950996 · 1995-10-03

ApplicantDaimler-Benz Aerospace
Decision Date1995-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER THERMAFOCUS 360 FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Daimler-Benz Aerospace. It received FDA 510(k) clearance on 1995-10-03 under 510(k) number K950996. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DORNIER THERMAFOCUS 360 FIBER?

DORNIER THERMAFOCUS 360 FIBER is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Daimler-Benz Aerospace. The 510(k) number is K950996.

When did DORNIER THERMAFOCUS 360 FIBER receive FDA 510(k) clearance?

DORNIER THERMAFOCUS 360 FIBER received FDA 510(k) clearance on 1995-10-03, under 510(k) number K950996.

Who is the listed applicant for DORNIER THERMAFOCUS 360 FIBER?

The FDA 510(k) record lists Daimler-Benz Aerospace as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORNIER THERMAFOCUS 360 FIBER?

The FDA product code for DORNIER THERMAFOCUS 360 FIBER is GEX. This falls under the Gastroenterology category.

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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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