The following data is part of a premarket notification filed by Chase Medical, Inc. with the FDA for Chase Temperature Probe.
| Device ID | K971013 |
| 510k Number | K971013 |
| Device Name: | CHASE TEMPERATURE PROBE |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | CHASE MEDICAL, INC. 1876 FIRMAN DR. Richardson, TX 75081 |
| Contact | Bert Davis |
| Correspondent | Bert Davis CHASE MEDICAL, INC. 1876 FIRMAN DR. Richardson, TX 75081 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-10-28 |
| Summary: | summary |