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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K003561
Device Name INVACARE PASSOVER HUMIDIFIER MODEL ISP9700
Applicant
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036 -2125
Applicant Contact RAE ANN FARROW
Correspondent
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036 -2125
Correspondent Contact RAE ANN FARROW
Regulation Number868.5450
Classification Product Code
BTT  
Date Received11/20/2000
Decision Date 04/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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