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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 K962603
Device Name MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
Applicant
Masimo Corp.
23361 Madero St.
Suite 100
Mission Viejo,  CA  92691
Applicant Contact JAMES J CRONIN
Correspondent
Masimo Corp.
23361 Madero St.
Suite 100
Mission Viejo,  CA  92691
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/02/1996
Decision Date 02/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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