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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 K061874
Device Name INVACARE'S TWILIGHT II NASAL MASKS
Applicant
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036
Applicant Contact JANICE BROWNLEE
Correspondent
INVACARE CORP.
ONE INVACARE WAY
ELYRIA,  OH  44036
Correspondent Contact JANICE BROWNLEE
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/03/2006
Decision Date 09/05/2006
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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