The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird Sentry Air/oxygen Microblender.
Device ID | K911962 |
510k Number | K911962 |
Device Name: | BIRD SENTRY AIR/OXYGEN MICROBLENDER |
Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
Contact | Bentinck |
Correspondent | Bentinck BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
Product Code | BZR |
CFR Regulation Number | 868.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-02 |
Decision Date | 1991-10-08 |