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FDA 510(k)

GERATHERM UNIQUERESC

K-Number: K093694 · 2010-09-20

ApplicantGeratherm Medical AG
Decision Date2010-09-20
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GERATHERM UNIQUERESC is the device name listed in this FDA 510(k) record. The listed applicant is Geratherm Medical AG. It received FDA 510(k) clearance on 2010-09-20 under 510(k) number K093694. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GERATHERM UNIQUERESC?

GERATHERM UNIQUERESC is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Geratherm Medical AG. The 510(k) number is K093694.

When did GERATHERM UNIQUERESC receive FDA 510(k) clearance?

GERATHERM UNIQUERESC received FDA 510(k) clearance on 2010-09-20, under 510(k) number K093694.

Who is the listed applicant for GERATHERM UNIQUERESC?

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

What is the FDA product code for GERATHERM UNIQUERESC?

The FDA product code for GERATHERM UNIQUERESC is DWJ.

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Other records listing Geratherm Medical AG as applicant

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.

K093244UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX

Related Devices (Code: DWJ)

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.

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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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