The following data is part of a premarket notification filed by Omp Laboratories, Inc. with the FDA for Syringe Set, 3-way Thermodilutin.
| Device ID | K760402 |
| 510k Number | K760402 |
| Device Name: | SYRINGE SET, 3-WAY THERMODILUTIN |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | OMP LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-06 |
| Decision Date | 1976-08-23 |