FDA 510(k) Application Details - K192199

Device Classification Name	Calibrator, Dose, Radionuclide   More FDA Info for this Device
510(K) Number	K192199
Device Name	Calibrator, Dose, Radionuclide
Applicant	Capintec, Inc. 7 Vreeland Road Florham Park, NJ 07932 US Other 510(k) Applications for this Company
Contact	Mary Anne Yusko Other 510(k) Applications for this Contact
Regulation Number	892.1360   More FDA Info for this Regulation Number
Classification Product Code	KPT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2019
Decision Date	09/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review