MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER


Device Classification Name

oximeter

510(k) Number K080238
Device Name MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
Applicant
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Applicant Contact marquerite thomlinson
Correspondent
MASIMO CORPORATION
40 parker
irvine, 
CA 
92618

Correspodent Contact marquerite thomlinson
Regulation Number 870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DPZ   JKS  
Date Received 01/31/2008
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No