MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500


definition

Device Classification Name

oximeter

510(k) Number K001085
Device Name MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
Original Applicant
NONIN MEDICAL, INC.
2605 fernbrook lane, north
minneapolis, 
MN 
55447 -4755

Original Contact richard p bennett
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 04/04/2000
Decision Date 05/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No