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FDA 510(k)

HUMICARE D900

K-Number: K122705 · 2013-05-21

ApplicantGrundler GmbH
Decision Date2013-05-21
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMICARE D900 is the device name listed in this FDA 510(k) record. The listed applicant is Grundler GmbH. It received FDA 510(k) clearance on 2013-05-21 under 510(k) number K122705. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMICARE D900?

HUMICARE D900 is a medical device that received FDA 510(k) clearance on 2013-05-21. The listed applicant is Grundler GmbH. The 510(k) number is K122705.

When did HUMICARE D900 receive FDA 510(k) clearance?

HUMICARE D900 received FDA 510(k) clearance on 2013-05-21, under 510(k) number K122705.

Who is the listed applicant for HUMICARE D900?

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

What is the FDA product code for HUMICARE D900?

The FDA product code for HUMICARE D900 is BTT.

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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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