DeviceClearance

Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20— 510(k) K221955

Substantially Equivalent

Realcloud Imaging Inc. Dba Realcloud Imaging

FDA 510(k) clearance K221955 for Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20, Substantially Equivalent on 2022-08-31. Applicant: Realcloud Imaging Inc. Dba Realcloud Imaging. Device class: 2.

Clearance details

Applicant
Realcloud Imaging Inc. Dba Realcloud Imaging
Product code
Code MUH
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ames, IA, US
Download summary PDFView on FDA.gov ↗

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