Ultrasound System 1300

System, Imaging, Pulsed Doppler, Ultrasonic

BK Medical ApS

The following data is part of a premarket notification filed by Bk Medical Aps with the FDA for Ultrasound System 1300.

Pre-market Notification Details

Device IDK173569
510k NumberK173569
Device Name:Ultrasound System 1300
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant BK Medical ApS Mileparken 34 Herlev,  DK 2730
ContactKaren Provencher
CorrespondentKaren Provencher
BK Medical ApS Mileparken 34 Herlev,  DK 2730
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-11-20
Decision Date2018-02-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05704916001285 K173569 000
05704916001698 K173569 000
05704916001407 K173569 000
05704916001414 K173569 000
05704916001421 K173569 000
05704916001438 K173569 000
05704916001445 K173569 000
05704916001513 K173569 000
05704916001520 K173569 000
05704916001551 K173569 000
05704916001568 K173569 000
05704916001575 K173569 000
05704916001582 K173569 000
05704916000325 K173569 000
05704916000363 K173569 000
05704916000370 K173569 000
05704916001667 K173569 000

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