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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 Rd., Suites B1-B4
Coconut Creek,  FL  33073
Applicant Contact LINDA MAGILL
Correspondent
Innomed Technologies, Inc./Respcare, Inc.
6601 Lyons Rd., 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
Predetermined Change
Control Plan Authorized		 No
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