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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 K973887
Device Name MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES
Applicant
MASIMO CORP.
2852 KELVIN AVE.
IRVINE,  CA  92614 -5826
Applicant Contact JAMES J CRONIN
Correspondent
MASIMO CORP.
2852 KELVIN AVE.
IRVINE,  CA  92614 -5826
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/14/1997
Decision Date 01/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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