The following data is part of a premarket notification filed by Bird Products Corp. with the FDA for Tbird Vs/avs Volume Ventilator, Models 15568, 15570 , Lp10 Volume Ventilator With Pressure Limit Model 00-004130, Bear 3.
| Device ID | K981971 |
| 510k Number | K981971 |
| Device Name: | TBIRD VS/AVS VOLUME VENTILATOR, MODELS 15568, 15570 , LP10 VOLUME VENTILATOR WITH PRESSURE LIMIT MODEL 00-004130, BEAR 3 |
| Classification | Ventilator, Continuous, Facility Use |
| 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 | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-04 |
| Decision Date | 1998-08-24 |
| Summary: | summary |