MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT


definition

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
Original Applicant
MASIMO CORP.
2852 kelvin ave.
irvine, 
CA 
92614 -5826

Original Contact james j cronin
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 08/18/2000
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