FINGER PULSE OXIMETER, MODEL 9560


Device Classification Name

oximeter

510(k) Number K081285
Device Name FINGER PULSE OXIMETER, MODEL 9560
Applicant
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth, 
MN 
55441 -5443

Applicant Contact lori m roth
Correspondent
NONIN MEDICAL, INC.
13700 1st ave. north
plymouth, 
MN 
55441 -5443

Correspodent Contact lori m roth
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 05/06/2008
Decision Date 06/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No