The following data is part of a premarket notification filed by Sorensen Research with the FDA for Flow-directed Thermodilution Catheter.
| Device ID | K812800 |
| 510k Number | K812800 |
| Device Name: | FLOW-DIRECTED THERMODILUTION CATHETER |
| Classification | Probe, Thermodilution |
| Applicant | SORENSEN RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-06 |
| Decision Date | 1981-10-20 |