The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed Av2+ Anesthesia Ventilator.
Device ID | K953228 |
510k Number | K953228 |
Device Name: | NARKOMED AV2+ ANESTHESIA VENTILATOR |
Classification | Ventilator, Continuous, Facility Use |
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 | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-10 |
Decision Date | 1996-03-01 |