The following data is part of a premarket notification filed by Douglas Products with the FDA for Sonic Mist Ultrasonic Humidifier.
| Device ID | K831646 |
| 510k Number | K831646 |
| Device Name: | SONIC MIST ULTRASONIC HUMIDIFIER |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | DOUGLAS PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-19 |
| Decision Date | 1983-07-12 |