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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 K090804
Device Name NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD
Applicant
INNOMED TECHNOLOGIES INC./RESPCARE INC.
6601 LYONS ROAD
SUITES B1-B4
COCONUT CREEK,  FL  33073
Applicant Contact LINDA MAGILL
Correspondent
INNOMED TECHNOLOGIES INC./RESPCARE INC.
6601 LYONS ROAD
SUITES B1-B4
COCONUT CREEK,  FL  33073
Correspondent Contact LINDA MAGILL
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/25/2009
Decision Date 11/05/2009
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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