The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for P/n 9320 Low Flow Air/oxygen Microblender.
| Device ID | K883038 |
| 510k Number | K883038 |
| Device Name: | P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | William C Bentinck |
| Correspondent | William C 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 | 1988-07-19 |
| Decision Date | 1988-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752174658 | K883038 | 000 |
| 10190752160750 | K883038 | 000 |
| 10190752181939 | K883038 | 000 |
| 10190752174610 | K883038 | 000 |
| 10846446063813 | K883038 | 000 |
| 10846446002454 | K883038 | 000 |