The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Wh150 Room Humidifier.
Device ID | K871661 |
510k Number | K871661 |
Device Name: | WH150 ROOM 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 | 1987-04-28 |
Decision Date | 1987-06-15 |