The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Drager Vapor 19.1 Anesthetic Vaporizers.
Device ID | K821650 |
510k Number | K821650 |
Device Name: | DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | DRAEGER MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-04 |
Decision Date | 1982-06-29 |