The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Spectramed Respiratory Gas Analyzer.
| Device ID | K873194 |
| 510k Number | K873194 |
| Device Name: | SPECTRAMED RESPIRATORY GAS ANALYZER |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Contact | Perk Crook |
| Correspondent | Perk Crook DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-13 |
| Decision Date | 1987-10-30 |