The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Bear Cub Infant Pressure Ventilator.
| Device ID | K955865 |
| 510k Number | K955865 |
| Device Name: | BEAR CUB INFANT PRESSURE VENTILATOR |
| 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 | 1995-12-28 |
| Decision Date | 1996-08-06 |