The following data is part of a premarket notification filed by Percussionaire Corp. with the FDA for Percussionaire Oscillatron-1 Medical Respirator.
| Device ID | K892886 |
| 510k Number | K892886 |
| Device Name: | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864 |
| Contact | Bird, Md |
| Correspondent | Bird, Md PERCUSSIONAIRE CORP. BIRD AIRLODGE, GLENGARY BAY P.O. BOX 817 Sandpoint, ID 83864 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-19 |
| Decision Date | 1989-10-27 |