The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Open Reservoir Scavenger.
| Device ID | K864034 |
| 510k Number | K864034 |
| Device Name: | OPEN RESERVOIR SCAVENGER |
| Classification | Apparatus, Gas-scavenging |
| Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Contact | Edward T Griffith |
| Correspondent | Edward T Griffith DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-15 |
| Decision Date | 1986-12-15 |