The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Thermodilution Kit.
| Device ID | K811480 |
| 510k Number | K811480 |
| Device Name: | THERMODILUTION KIT |
| Classification | Probe, Thermodilution |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-27 |
| Decision Date | 1981-06-09 |