The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed 3 Anesthesia System.
Device ID | K900329 |
510k Number | K900329 |
Device Name: | NARKOMED 3 ANESTHESIA SYSTEM |
Classification | Gas-machine, Anesthesia |
Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
Contact | James Brennan |
Correspondent | James 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 | 1990-01-23 |
Decision Date | 1990-02-01 |