MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES


codes

Device Classification Name

oximeter

510(k) Number K002477
Device Name MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
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 08/11/2000
Decision Date 09/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No