SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664

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

NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP.

The following data is part of a premarket notification filed by Northern Electric Co. Div. Of Sunbeam Corp. with the FDA for Sunbeam Evaporative Humidifier 663 & 664.

Pre-market Notification Details

Device IDK851220
510k NumberK851220
Device Name:SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664
ClassificationHumidifier, Non-direct Patient Interface (home-use)
Applicant NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. 5224 NORTH KEDZIE Chicago,  IL  60625
ContactScheck
CorrespondentScheck
NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. 5224 NORTH KEDZIE Chicago,  IL  60625
Product CodeKFZ  
CFR Regulation Number868.5460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-26
Decision Date1985-09-17

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