The following data is part of a premarket notification filed by Traverse Medical Monitors with the FDA for Tmm Model 3000 Anesthesia Circuit Evaluator.
| Device ID | K863801 |
| 510k Number | K863801 |
| Device Name: | TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | TRAVERSE MEDICAL MONITORS 6812 S. STATE RD. Saline, MI 48176 |
| Contact | Timothy J Bomya |
| Correspondent | Timothy J Bomya TRAVERSE MEDICAL MONITORS 6812 S. STATE RD. Saline, MI 48176 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-29 |
| Decision Date | 1987-01-12 |