510(k) K962220

HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER by Marquest Medical Products, Inc. — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1997
Date Received
June 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type