MASIMO RADICAL Y PULSE CO-OXIMETER


Device Classification Name

oximeter

510(k) Number K110028
Device Name MASIMO RADICAL Y PULSE CO-OXIMETER
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
DQA  
Subsequent Product Codes
BZQ   DPZ   JKS  
Date Received 01/05/2011
Decision Date 03/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No