E1 EAR SENSORS


Device Classification Name

oximeter

510(k) Number K121912
Device Name E1 EAR SENSORS
Applicant
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Applicant Contact david collette
Correspondent
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Correspodent Contact david collette
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 07/02/2012
Decision Date 07/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No