ULTRASOUND SCANNER, TYPE 2400


Device Classification Name

system, imaging, pulsed doppler, ultrasonic

510(k) Number K024236
Device Name ULTRASOUND SCANNER, TYPE 2400
Original Applicant
B-K MEDICAL A/S
mileparken 34
herlev, 

DK

dk-2730

Original Contact villy braender
Regulation Number 892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received 12/23/2002
Decision Date 01/17/2003
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