The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Drager Dve 4000 Series System.
| Device ID | K921297 |
| 510k Number | K921297 |
| Device Name: | DRAGER DVE 4000 SERIES SYSTEM |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | ALM SURGICAL EQUIPMENT, INC. 3323 WEST WARNER AVE. Santa Ana, CA 92704 |
| Contact | Karen Young |
| Correspondent | Karen Young ALM SURGICAL EQUIPMENT, INC. 3323 WEST WARNER AVE. Santa Ana, CA 92704 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-17 |
| Decision Date | 1992-11-27 |