INTRABEAM 600— 510(k) K162568

Substantially Equivalent

Carl Zeiss Meditec, AG

FDA 510(k) clearance K162568 for INTRABEAM 600, Substantially Equivalent on 2016-12-15. Applicant: Carl Zeiss Meditec, AG. Device class: 2.

Clearance details

Applicant
Carl Zeiss Meditec, AG
Product code
Code JAD
Device class
Class 2
Regulation
21 CFR 892.5900
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jena, DE
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