ECAT SCINTRON PET— 510(k) K130269

Substantially Equivalent

Miegmbh

FDA 510(k) clearance K130269 for ECAT SCINTRON PET, Substantially Equivalent on 2013-04-19. Applicant: Miegmbh. Device class: 2.

Clearance details

Applicant: Miegmbh
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2013-02-04
Decision date: 2013-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seth, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.