The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Drager Micro Vent.
Device ID | K953238 |
510k Number | K953238 |
Device Name: | DRAGER MICRO VENT |
Classification | Ventilator, Continuous, Facility Use |
Applicant | DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
Contact | Harald Kneuer |
Correspondent | Harald Kneuer DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly, VA 22021 |
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 | 1995-07-11 |
Decision Date | 1996-09-16 |