ULTRASOUND SCANNER, TYPE 1101


definition

Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K002085
Device Name ULTRASOUND SCANNER, TYPE 1101
Original Applicant
B & K MEDICAL A/S
sandtoften 9
dk 2820 gentofte, 

DK

Original Contact villy braender
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 07/10/2000
Decision Date 08/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Special
Reviewed by Third Party No

Combination Product

No