LYNX ULTRASOUND SYSTEM


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K991872
Device Name LYNX ULTRASOUND SYSTEM
Applicant
ECTON, INC.
110 west butler ave., #100
ambler, 
PA 
19002 -9998

Applicant Contact christopher b knell
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 06/01/1999
Decision Date 06/16/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No