The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Sh20, Sh30 & Sh50 Ultrasonic Humidifier.
| Device ID | K862042 |
| 510k Number | K862042 |
| Device Name: | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
| Contact | John Jiambalvo |
| Correspondent | John Jiambalvo ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-28 |
| Decision Date | 1986-06-05 |