The following data is part of a premarket notification filed by Radiant Medical with the FDA for Radiant Medical Endocatheter Temperature Probe.
| Device ID | K042388 |
| 510k Number | K042388 |
| Device Name: | RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE |
| Classification | Catheter, Percutaneous |
| Applicant | RADIANT MEDICAL 250 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Andrew Cleeland |
| Correspondent | Andrew Cleeland RADIANT MEDICAL 250 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-09-02 |
| Decision Date | 2004-10-28 |
| Summary: | summary |