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FDA 510(k)

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20

K-Number: K221955 · 2022-08-31

ApplicantRealcloud Imaging Inc. Dba Realcloud Imaging
Decision Date2022-08-31
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is the device name listed in this FDA 510(k) record. The listed applicant is Realcloud Imaging Inc. Dba Realcloud Imaging. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221955. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is Realcloud Imaging Inc. Dba Realcloud Imaging. The 510(k) number is K221955.

When did Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 receive FDA 510(k) clearance?

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221955.

Who is the listed applicant for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?

The FDA 510(k) record lists Realcloud Imaging Inc. Dba Realcloud Imaging as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?

The FDA product code for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is MUH.

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Official Source

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