The following data is part of a premarket notification filed by North American Grager with the FDA for Drager-vapor 19.1.
Device ID | K942055 |
510k Number | K942055 |
Device Name: | DRAGER-VAPOR 19.1 |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | NORTH AMERICAN GRAGER 148 B QUARRY RD. Telford, PA 18969 |
Contact | James J Brennan |
Correspondent | James J Brennan NORTH AMERICAN GRAGER 148 B 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 | 1994-04-28 |
Decision Date | 1995-01-27 |