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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 K161719
Device Name Salter Labs Bubble Humidifier
Applicant
SALTER LABS
2365 CAMINO VIDA ROBLE
Carlsbad,  CA  92011
Applicant Contact MARA CALER
Correspondent
SALTER LABS
2365 CAMINO VIDA ROBLE
Carlsbad,  CA  92011
Correspondent Contact MARA CALER
Regulation Number868.5450
Classification Product Code
BTT  
Date Received06/22/2016
Decision Date 09/21/2017
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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