MASIMO SET USPO2 PULSE OXIMETRY CABLE


Device Classification Name

oximeter

510(k) Number K121914
Device Name MASIMO SET USPO2 PULSE OXIMETRY CABLE
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 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls