ULTRASOUND SCANNER, TYPE 2400

System, Imaging, Pulsed Doppler, Ultrasonic

B-K MEDICAL A/S

The following data is part of a premarket notification filed by B-k Medical A/s with the FDA for Ultrasound Scanner, Type 2400.

Pre-market Notification Details

Device IDK024236
510k NumberK024236
Device Name:ULTRASOUND SCANNER, TYPE 2400
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant B-K MEDICAL A/S MILEPARKEN 34 Herlev,  DK Dk-2730
ContactVilly Braender
CorrespondentVilly Braender
B-K MEDICAL A/S MILEPARKEN 34 Herlev,  DK Dk-2730
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-23
Decision Date2003-01-17
Summary:summary

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