COOK-SWARTZ DOPPLER FLOW PROBE


Device Classification Name

transducer, ultrasonic, diagnostic

510(k) Number K022649
Device Name COOK-SWARTZ DOPPLER FLOW PROBE
Original Applicant
COOK VASCULAR, INC.
rt. 66, river rd.
p.o. box 529
leechburg, 
PA 
15656 -0529

Original Contact thomas j kardos
Regulation Number 892.1570
Classification Product Code
ITX  
Date Received 08/09/2002
Decision Date 09/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No