MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V

Device Classification Name

oximeter

510(k) Number K033296
Device Name MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
Applicant
MASIMO CORP.
2852 kelvin ave.
irvine, 
CA 
92614 -5826

Applicant Contact james j cronin
Correspondent
MASIMO CORP.
2852 kelvin ave.
irvine, 
CA 
92614 -5826

Correspodent Contact james j cronin
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 10/14/2003
Decision Date 02/19/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No