CRC PC WITH SMART CHAMBER— 510(k) K141413

Substantially Equivalent

Capintec, Inc.

FDA 510(k) clearance K141413 for CRC PC WITH SMART CHAMBER, Substantially Equivalent on 2014-06-27. 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: 2014-05-29
Decision date: 2014-06-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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