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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 K002574
Device Name MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
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 Received08/18/2000
Decision Date 09/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
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