The following data is part of a premarket notification filed by Stein-gates Medical Equipment, Inc. with the FDA for Omni-vent, Series D/mri.
| Device ID | K881420 |
| 510k Number | K881420 |
| Device Name: | OMNI-VENT, SERIES D/MRI |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | STEIN-GATES MEDICAL EQUIPMENT, INC. 121 NORTH FOURTH ST. Atchison, KS 66002 |
| Contact | William Gates |
| Correspondent | William Gates STEIN-GATES MEDICAL EQUIPMENT, INC. 121 NORTH FOURTH ST. Atchison, KS 66002 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-06-14 |