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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 K143700
FOIA Releasable 510(k) K143700
Device Name CPAP Cannulaide
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Applicant Contact Aurelia Brownridge
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Correspondent Contact Aurelia Brownridge
Regulation Number868.5905
Classification Product Code
Date Received12/24/2014
Decision Date 08/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No