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FDA 510(k)

TECHNOSANAT KRYO TSK 2005

K-Number: K992536 · 1999-10-08

ApplicantTechnosanat Innovative Medizintechnik GmbH
Decision Date1999-10-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TECHNOSANAT KRYO TSK 2005 is the device name listed in this FDA 510(k) record. The listed applicant is Technosanat Innovative Medizintechnik GmbH. It received FDA 510(k) clearance on 1999-10-08 under 510(k) number K992536. 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 TECHNOSANAT KRYO TSK 2005?

TECHNOSANAT KRYO TSK 2005 is a medical device that received FDA 510(k) clearance on 1999-10-08. The listed applicant is Technosanat Innovative Medizintechnik GmbH. The 510(k) number is K992536.

When did TECHNOSANAT KRYO TSK 2005 receive FDA 510(k) clearance?

TECHNOSANAT KRYO TSK 2005 received FDA 510(k) clearance on 1999-10-08, under 510(k) number K992536.

Who is the listed applicant for TECHNOSANAT KRYO TSK 2005?

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

What is the FDA product code for TECHNOSANAT KRYO TSK 2005?

The FDA product code for TECHNOSANAT KRYO TSK 2005 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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