The following data is part of a premarket notification filed by Praxair, Inc. with the FDA for Praxair Medical Air Mixer.
Device ID | K051192 |
510k Number | K051192 |
Device Name: | PRAXAIR MEDICAL AIR MIXER |
Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
Applicant | PRAXAIR, INC. 175 EAST PARK DR. 2/144 Tonawanda, NY 14150 |
Contact | Tamara Brown |
Correspondent | Tamara Brown PRAXAIR, INC. 175 EAST PARK DR. 2/144 Tonawanda, NY 14150 |
Product Code | BZR |
CFR Regulation Number | 868.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-10 |
Decision Date | 2005-09-06 |
Summary: | summary |