WH150 ROOM HUMIDIFIER

Humidifier, Non-direct Patient Interface (home-use)

ASSOCIATED MILLS, INC.

The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Wh150 Room Humidifier.

Pre-market Notification Details

Device IDK871661
510k NumberK871661
Device Name:WH150 ROOM HUMIDIFIER
ClassificationHumidifier, Non-direct Patient Interface (home-use)
Applicant ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago,  IL  60606
ContactJohn Jiambalvo
CorrespondentJohn Jiambalvo
ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago,  IL  60606
Product CodeKFZ  
CFR Regulation Number868.5460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-28
Decision Date1987-06-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.