The following data is part of a premarket notification filed by Stein-gates Medical Equipment, Inc. with the FDA for Omni-vent, Series D.
| Device ID | K872113 |
| 510k Number | K872113 |
| Device Name: | OMNI-VENT, SERIES D |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | STEIN-GATES MEDICAL EQUIPMENT, INC. 121 NORTH FOURTH ST. Atchison, KS 66002 |
| Contact | Gates, Bs |
| Correspondent | Gates, Bs 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 | 1987-06-01 |
| Decision Date | 1988-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000180 | K872113 | 000 |
| 00026072000182 | K872113 | 000 |