The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Drager-vapor 2000.
| Device ID | K971923 |
| 510k Number | K971923 |
| Device Name: | DRAGER-VAPOR 2000 |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Contact | James J Brennan |
| Correspondent | James J Brennan DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-23 |
| Decision Date | 1997-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675301363 | K971923 | 000 |
| 04048675228059 | K971923 | 000 |