The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Humid-vent Trach-vent.
| Device ID | K952845 |
| 510k Number | K952845 |
| Device Name: | HUMID-VENT TRACH-VENT |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-21 |
| Decision Date | 1995-07-25 |