The following data is part of a premarket notification filed by Capintec, Inc. with the FDA for Crc Pc With Smart Chamber.
| Device ID | K141413 |
| 510k Number | K141413 |
| Device Name: | CRC PC WITH SMART CHAMBER |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15241 |
| Contact | Mary Anne Yusko |
| Correspondent | Mary Anne Yusko CAPINTEC, INC. 620 ALPHA DR. Pittsburgh, PA 15241 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-29 |
| Decision Date | 2014-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859942006089 | K141413 | 000 |
| 00859942006072 | K141413 | 000 |