The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for 225 S.i.m.v. Ventilator.
| Device ID | K822635 |
| 510k Number | K822635 |
| Device Name: | 225 S.I.M.V. VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | MONAGHAN MEDICAL CORP. 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 | 1982-08-31 |
| Decision Date | 1982-11-16 |