The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Critical Care Ventilator 2.
| Device ID | K772065 |
| 510k Number | K772065 |
| Device Name: | CRITICAL CARE VENTILATOR 2 |
| 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 | 1977-11-02 |
| Decision Date | 1977-11-28 |