MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE


Device Classification Name

oximeter

510(k) Number K022677
Device Name MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
Original Applicant
ALARIS MEDICAL SYSTEMS, INC.
10221 wateridge cir.
san diego, 
CA 
92121

Original Contact renee l fluet
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 08/12/2002
Decision Date 09/11/2002
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