The following data is part of a premarket notification filed by Bear Medical Systems, Inc. with the FDA for Ptr Mk Ii Ventilator.
| Device ID | K860692 |
| 510k Number | K860692 |
| Device Name: | PTR MK II VENTILATOR |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Ray Pizinger |
| Correspondent | Ray Pizinger BEAR MEDICAL SYSTEMS, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-25 |
| Decision Date | 1986-05-21 |