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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K113542
Device Name SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
Applicant
SALTER LABS, ARVIN FACILITY
100 Sycamore Rd
ARVIN,  CA  93203
Applicant Contact MICHAEL SHOUP
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received12/01/2011
Decision Date 02/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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