REPROCESSED MASIMO PULSE OXIMETER SENSORS


Device Classification Name

oximeter, reprocessed

510(k) Number K081238
Device Name REPROCESSED MASIMO PULSE OXIMETER SENSORS
Applicant
ASCENT HEALTHCARE SOLUTIONS
10232 south 51st st.
phoenix, 
AZ 
85044

Applicant Contact katie bray
Correspondent
ASCENT HEALTHCARE SOLUTIONS
10232 south 51st st.
phoenix, 
AZ 
85044

Correspodent Contact katie bray
Regulation Number 870.2700
Classification Product Code
NLF  
Date Received 05/01/2008
Decision Date 07/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No