The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Ventilator #1.
| Device ID | K830488 |
| 510k Number | K830488 |
| Device Name: | VENTILATOR #1 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | OHIO MEDICAL PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-09-15 |