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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K022642
Device Name TWLIGHT, MODEL ISP 9600
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 Number868.5905
Classification Product Code
BZD  
Date Received08/08/2002
Decision Date 02/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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