M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS


Device Classification Name

oximeter, reprocessed

510(k) Number K110723
Device Name M-LNCS OXIMETRY SENSORS, REPROCESSED M-LNCS OXIMETRY SENSORS
Applicant
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Applicant Contact shelly harris
Correspondent
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Correspodent Contact shelly harris
Regulation Number 870.2700
Classification Product Code
NLF  
Subsequent Product Codes
DQA   DSA  
Date Received 03/16/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No