The following data is part of a premarket notification filed by Mountain Medical Equipment, Inc. with the FDA for Oxygen Concentration Status Indicator (o.c.s.i.).
| Device ID | K941793 |
| 510k Number | K941793 |
| Device Name: | OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.) |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
| Contact | Linda Chapman |
| Correspondent | Linda Chapman MOUNTAIN MEDICAL EQUIPMENT, INC. 10488 WEST CENTENNIAL RD. Littleton, CO 80127 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-11 |
| Decision Date | 1995-06-21 |