The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Rams (random Access Mass Spectrometer) M-200 Respiratory Gas Monitor.
| Device ID | K950101 |
| 510k Number | K950101 |
| Device Name: | RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | S Chmitz |
| Correspondent | S Chmitz MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-11 |
| Decision Date | 1995-03-21 |