ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K081154
Device Name ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
Applicant
B-K MEDICAL APS
mileparken 34
herlev, 

DK

dk-2730

Applicant Contact jens rasmussen
Correspondent
B-K MEDICAL APS
mileparken 34
herlev, 

DK

dk-2730

Correspodent Contact jens rasmussen
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN  
Date Received 04/23/2008
Decision Date 05/23/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No