CRC PC WITH SMART CHAMBER

Calibrator, Dose, Radionuclide

CAPINTEC, INC.

The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc Pc With Smart Chamber.

Pre-market Notification Details

Device IDK141413
510k NumberK141413
Device Name:CRC PC WITH SMART CHAMBER
ClassificationCalibrator, Dose, Radionuclide
Applicant CAPINTEC, INC. 620 ALPHA DR. Pittsburgh,  PA  15241
ContactMary Anne Yusko
CorrespondentMary Anne Yusko
CAPINTEC, INC. 620 ALPHA DR. Pittsburgh,  PA  15241
Product CodeKPT  
CFR Regulation Number892.1360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-29
Decision Date2014-06-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859942006089 K141413 000
00859942006072 K141413 000

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