The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/analyzer.
| Device ID | K973646 |
| 510k Number | K973646 |
| Device Name: | BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | Neil Battiste |
| Correspondent | Neil Battiste 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 | 1997-09-24 |
| Decision Date | 1998-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752181601 | K973646 | 000 |
| 10190752174719 | K973646 | 000 |
| 10190752174672 | K973646 | 000 |
| 10190752174641 | K973646 | 000 |
| 10190752174634 | K973646 | 000 |
| 10190752160811 | K973646 | 000 |
| 10190752147072 | K973646 | 000 |
| 10190752181991 | K973646 | 000 |
| 10190752181960 | K973646 | 000 |
| 10190752181588 | K973646 | 000 |
| 10190752174733 | K973646 | 000 |
| 10190752174740 | K973646 | 000 |
| 10190752181922 | K973646 | 000 |
| 10190752181984 | K973646 | 000 |
| 10190752174764 | K973646 | 000 |
| 10190752174757 | K973646 | 000 |
| 10190752174726 | K973646 | 000 |
| 10190752174702 | K973646 | 000 |
| 10190752174696 | K973646 | 000 |
| 10190752174689 | K973646 | 000 |
| 10190752147034 | K973646 | 000 |
| 10190752182004 | K973646 | 000 |
| 10190752160774 | K973646 | 000 |