ULTRASOUND SCANNER, MODEL TYPE 2101


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K991937
Device Name ULTRASOUND SCANNER, MODEL TYPE 2101
Applicant
B & K MEDICAL A/S
sandtoften 9
dk 2820 gentofte, 

DK

Applicant Contact villy braender
Correspondent
B & K MEDICAL A/S
sandtoften 9
dk 2820 gentofte, 

DK

Correspodent Contact villy braender
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 06/09/1999
Decision Date 07/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls