MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES


Device Classification Name

oximeter

510(k) Number K111403
Device Name MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
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  
Subsequent Product Code
GLY  
Date Received 05/19/2011
Decision Date 12/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No