The following data is part of a premarket notification filed by 3m Company with the FDA for Hymidifier.
| Device ID | K780088 |
| 510k Number | K780088 |
| Device Name: | HYMIDIFIER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-13 |
| Decision Date | 1978-02-02 |