PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K021984
Device Name PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT
Original Applicant
INCEPTIO MEDICAL TECHNOLOGIES, LC
1401 north highway 89
farmington, 
UT 
84025

Original Contact rosina robinson
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 06/18/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No