COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR


Device Classification Name

oximeter

510(k) Number K960251
Device Name COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR
Applicant
ARISTO MEDICAL PRODUCTS, INC.
407 pilot ct., #400-a
waukesha, 
WI 
53188

Applicant Contact stephen h gorski
Correspondent
ARISTO MEDICAL PRODUCTS, INC.
407 pilot ct., #400-a
waukesha, 
WI 
53188

Correspodent Contact stephen h gorski
Regulation Number 870.2700
Classification Product Code
DQA  
Date Received 01/18/1996
Decision Date 03/26/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No