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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 K992238
Device Name MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)
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 Received07/02/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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