The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc Pc Smart Chamber K1.
| Device ID | K192199 |
| 510k Number | K192199 |
| Device Name: | CRC PC Smart Chamber K1 |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | Capintec, Inc. 7 Vreeland Road Florham Park, NJ 07932 |
| Contact | Mary Anne Yusko |
| Correspondent | Mary Anne Yusko Capintec, Inc. 7 Vreeland Road Florham Park, NJ 07932 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-13 |
| Decision Date | 2019-09-12 |
| Summary: | summary |