DOPPLER MONITOR


Device Classification Name

flowmeter, blood, cardiovascular

510(k) Number K110347
Device Name DOPPLER MONITOR
Applicant
COOK VASCULAR, INC.
1186 montgomery lane
vandergrift, 
PA 
15690

Applicant Contact jim ferguson
Correspondent
COOK VASCULAR, INC.
1186 montgomery lane
vandergrift, 
PA 
15690

Correspodent Contact jim ferguson
Regulation Number 870.2100
Classification Product Code
DPW  
Subsequent Product Codes
ITX   JOP  
Date Received 02/07/2011
Decision Date 03/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No