PEM 2400 PET SCANNER— 510(k) K032063

Substantially Equivalent

Pem Technologies

FDA 510(k) clearance K032063 for PEM 2400 PET SCANNER, Substantially Equivalent on 2003-08-18. Applicant: Pem Technologies. Device class: 2.

Clearance details

Applicant: Pem Technologies
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2003-07-03
Decision date: 2003-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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