The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Trach Mist Unit W/or Without Elbow.
| Device ID | K800990 |
| 510k Number | K800990 |
| Device Name: | TRACH MIST UNIT W/OR WITHOUT ELBOW |
| Classification | Drain, Tee (water Trap) |
| Applicant | AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYH |
| CFR Regulation Number | 868.5995 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-24 |
| Decision Date | 1980-05-08 |