The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ohio Cpu-1 Intensive Care Ventilator.
| Device ID | K822888 |
| 510k Number | K822888 |
| Device Name: | OHIO CPU-1 INTENSIVE CARE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-28 |
| Decision Date | 1982-11-16 |