The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed 2c Anesthesia System.
Device ID | K930351 |
510k Number | K930351 |
Device Name: | NARKOMED 2C ANESTHESIA SYSTEM |
Classification | Gas-machine, Anesthesia |
Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
Contact | James J Brennan |
Correspondent | James J Brennan DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-25 |
Decision Date | 1993-06-22 |