The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed 6000.
Device ID | K993826 |
510k Number | K993826 |
Device Name: | NARKOMED 6000 |
Classification | Monitor, St Segment |
Applicant | DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
Contact | Gale E Winarsky |
Correspondent | Gale E Winarsky DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford, PA 18969 |
Product Code | MLC |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-12 |
Decision Date | 2000-03-23 |
Summary: | summary |