WARMAIR SYSTEM

System, Thermal Regulating

CINCINNATI SUB-ZERO PRODUCTS, INC.

The following data is part of a premarket notification filed by Cincinnati Sub-zero Products, Inc. with the FDA for Warmair System.

Pre-market Notification Details

Device IDK910327
510k NumberK910327
Device Name:WARMAIR SYSTEM
ClassificationSystem, Thermal Regulating
Applicant CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati,  OH  45241
ContactDouglas Clark
CorrespondentDouglas Clark
CINCINNATI SUB-ZERO PRODUCTS, INC. 12011 MOSTELLER RD. Cincinnati,  OH  45241
Product CodeDWJ  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-25
Decision Date1991-05-16

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