RT Elements (4.0)— 510(k) K223279

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K223279 for RT Elements (4.0), Substantially Equivalent on 2023-03-14. Applicant: Brainlab AG. Device class: 2.

Clearance details

Applicant
Brainlab AG
Product code
Code MUJ
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Munich, DE
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