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510(k) K003561

INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 by Invacare Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2001
Date Received
November 20, 2000
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

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