The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for O.r. Data Manager.
Device ID | K900937 |
510k Number | K900937 |
Device Name: | O.R. DATA MANAGER |
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 | 1990-02-28 |
Decision Date | 1990-04-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
O.R. DATA MANAGER 74166815 1793435 Dead/Cancelled |
N.A.D. Inc. 1991-05-15 |