CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS— 510(k) K071396

Name: FDA 510(k) clearance K071396
Creator: U.S. Food and Drug Administration
Published: 2007-06-28

Substantially Equivalent

Capintec, Inc.

FDA 510(k) clearance K071396 for CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS, Substantially Equivalent on 2007-06-28. Applicant: Capintec, Inc.. Device class: 2.

Clearance details

Applicant: Capintec, Inc.
Product code: Code KPT
Device class: Class 2
Regulation: 21 CFR 892.1360
Advisory panel: Radiology
Date received: 2007-05-21
Decision date: 2007-06-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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