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.
Device ID | K851220 |
510k Number | K851220 |
Device Name: | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 |
Classification | Humidifier, Non-direct Patient Interface (home-use) |
Applicant | NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. 5224 NORTH KEDZIE Chicago, IL 60625 |
Contact | Scheck |
Correspondent | Scheck NORTHERN ELECTRIC CO. DIV. OF SUNBEAM CORP. 5224 NORTH KEDZIE Chicago, IL 60625 |
Product Code | KFZ |
CFR Regulation Number | 868.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-26 |
Decision Date | 1985-09-17 |