CRC PC Smart Chamber K1— 510(k) K192199

Substantially Equivalent

Capintec, Inc.

FDA 510(k) clearance K192199 for CRC PC Smart Chamber K1, Substantially Equivalent on 2019-09-12. Applicant: Capintec, Inc..

Clearance details

Applicant: Capintec, Inc.
Product code: Code KPT
Advisory panel: Radiology
Date received: 2019-08-13
Decision date: 2019-09-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Florham Park, NJ, US

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