MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS


Device Classification Name

oximeter

510(k) Number K111621
Device Name MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
Applicant
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Applicant Contact anil bhalani
Correspondent
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Correspodent Contact anil bhalani
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 06/10/2011
Decision Date 10/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No