Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
K-Number: K221955 · 2022-08-31
Decision Date2022-08-31
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is a medical device manufactured by Realcloud Imaging Inc. Dba Realcloud Imaging. It received FDA 510(k) clearance on 2022-08-31 under approval 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. It is manufactured by Realcloud Imaging Inc. Dba Realcloud Imaging. The 510(k) number is K221955.
When was Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 approved by the FDA?
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 received FDA 510(k) clearance on 2022-08-31, under approval number K221955.
What company makes Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20?
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 is manufactured by Realcloud Imaging Inc. Dba Realcloud Imaging.
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.
Related Devices (Code: MUH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.