The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Babybird Ventilator, Portable Lifecare Ventilator, External Pressure Limiter, Volume Ventilator With Pressure Limit.
| Device ID | K972203 |
| 510k Number | K972203 |
| Device Name: | BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Stanley E Fry |
| Correspondent | Stanley E Fry ALLIED HEALTHCARE PRODUCTS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| 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 | 1997-06-11 |
| Decision Date | 1997-11-06 |