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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(K) Number K100403
Model PRNTO-7
Device Name MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
Applicant
MASIMO CORPORATION
40 parker
irvine,  CA  92618
Contact marguerite thomlinson
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/16/2010
Decision Date 06/23/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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