510(k) K792620

NEONATAL HEATED HUMIDIFIER by Modern Medical Systems Co. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1980
Date Received
January 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type