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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 K102224
Device Name PIXI PEDIATRIC MASK
Applicant
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO,  CA  92123
Applicant Contact DAVID D'CRUZ
Correspondent
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO,  CA  92123
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/06/2010
Decision Date 12/10/2010
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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