The following data is part of a premarket notification filed by Thermix, Inc. with the FDA for Thermix Inc. Nasotherm Ii Personal Steam Machine.
| Device ID | K852283 |
| 510k Number | K852283 |
| Device Name: | THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | THERMIX, INC. 6019 S. INGLESIDE AVE., SU 102 Chicago, IL 60637 |
| Contact | David G Bostwick |
| Correspondent | David G Bostwick THERMIX, INC. 6019 S. INGLESIDE AVE., SU 102 Chicago, IL 60637 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-07-30 |