The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Pediatric Ventilator And Partner Volume Monitor.
| Device ID | K915488 |
| 510k Number | K915488 |
| Device Name: | PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Contact | W. C Bentinck |
| Correspondent | W. C Bentinck BIRD PRODUCTS CORP. 1100 BIRD CENTER DR. Palm Springs, CA 92262 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-06 |
| Decision Date | 1992-10-22 |