Curved Array Transducer

GUDID 05704916000608

Abdominal, Obstetrics, Fetal, Pediatrics

Bk Medical ApS

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID05704916000608
NIH Device Record Key87ad83ac-2be1-4c00-8d6b-3755cb3bf892
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurved Array Transducer
Version Model Number8830
Company DUNS310093901
Company NameBk Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4544528100
Emailinfo@bkultrasound.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105704916000608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-17

On-Brand Devices [Curved Array Transducer]

05704916000608Abdominal, Obstetrics, Fetal, Pediatrics
05704916000578Abdominal
05704916000554Abdominal, Obstetrics, Fetal

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.