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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
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