The following data is part of a premarket notification filed by Gibeck Respiration with the FDA for Stom-vent.
| Device ID | K872153 |
| 510k Number | K872153 |
| Device Name: | STOM-VENT |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | GIBECK RESPIRATION 8600 W. BRYN MAWR SUITE 200N Chicago, IL 60631 |
| Contact | Darryl Lustig |
| Correspondent | Darryl Lustig GIBECK RESPIRATION 8600 W. BRYN MAWR SUITE 200N Chicago, IL 60631 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-04 |
| Decision Date | 1987-08-03 |