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FDA 510(k)

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004

K-Number: K031225 · 2003-09-29

ApplicantGfe Medizintechnik GmbH
Decision Date2003-09-29
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 is the device name listed in this FDA 510(k) record. The listed applicant is Gfe Medizintechnik GmbH. It received FDA 510(k) clearance on 2003-09-29 under 510(k) number K031225. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004?

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 is a medical device that received FDA 510(k) clearance on 2003-09-29. The listed applicant is Gfe Medizintechnik GmbH. The 510(k) number is K031225.

When did TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 receive FDA 510(k) clearance?

TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 received FDA 510(k) clearance on 2003-09-29, under 510(k) number K031225.

Who is the listed applicant for TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004?

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

What is the FDA product code for TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004?

The FDA product code for TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 is FTL.

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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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