The following data is part of a premarket notification filed by Alm Surgical Equipment, Inc. with the FDA for Drager Dve 8080/81/82 With Dve 4002 Or Dve 4001 Series System.
| Device ID | K961742 |
| 510k Number | K961742 |
| Device Name: | DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM |
| Classification | Table, Operating-room, Ac-powered |
| Applicant | ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Contact | Susan Nielsen |
| Correspondent | Susan Nielsen ALM SURGICAL EQUIPMENT, INC. 1820 NORTH LEMON ST. Anaheim, CA 92801 -1009 |
| Product Code | FQO |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-06 |
| Decision Date | 1996-07-26 |
| Summary: | summary |