Medical Device Manufacturer · DK , Herlev

Bk Medical Aps - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2015

Recent clearances: Ultrasound System 1300, Ultrasound System 2300, Ultrasound System 2300

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bk Medical Aps Radiology ✕

9 devices

1-9 of 9

Cleared Oct 23, 2023

Ultrasound System 1300

Radiology · 129d

Cleared Apr 11, 2023

Ultrasound System 2300

Radiology · 111d

Cleared Dec 07, 2022

Ultrasound System 2300

Radiology · 117d

Cleared Aug 01, 2018

Ultrasound Scanner System bk2300

Radiology · 132d

Cleared Feb 23, 2018

Ultrasound System 1300

Radiology · 95d

Cleared Oct 17, 2016

Radiology · 91d

Cleared Oct 05, 2015

Ultrasound Scanner System BK2300

Radiology · 84d

Cleared Sep 16, 2015

Ultrasound Scanner System bk2300

Radiology · 55d

Cleared Jan 16, 2015

Ultrasound Scanner System bk2300

Radiology · 60d