CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS

Device Classification Name

calibrator, dose, radionuclide

510(k) Number K071396
Device Name CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS
Applicant
CAPINTEC, INC.
620 alpha dr.
pittsburgh, 
PA 
15241

Applicant Contact mary anne dell
Correspondent
CAPINTEC, INC.
620 alpha dr.
pittsburgh, 
PA 
15241

Correspodent Contact mary anne dell
Regulation Number 892.1360
Classification Product Code
KPT  
Date Received 05/21/2007
Decision Date 06/28/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls