Device Classification Name |
calibrator, dose, radionuclide
|
510(k) Number |
K192199 |
Device Name |
CRC PC Smart Chamber K1 |
Applicant |
Capintec, Inc. |
7 Vreeland Road |
Florham Park,
NJ
07932
|
|
Applicant Contact |
Mary Anne Yusko |
Correspondent |
Capintec, Inc. |
7 Vreeland Road |
Florham Park,
NJ
07932
|
|
Correspondent Contact |
Mary Anne Yusko |
Regulation Number | 892.1360
|
Classification Product Code |
|
Date Received | 08/13/2019 |
Decision Date | 09/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|