Medical Device Manufacturer · DK , Herlev

B-K Medical Aps - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2007

11

Total

11

Cleared

0

Denied

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

10 devices

1-10 of 10

Cleared May 30, 2014

ULTRASOUND SCANNER SYSTEM BK2300

Radiology · 100d

Cleared Jan 10, 2014

ULTRASOUND SCANNER FLEX FOCUS 1202

Radiology · 168d

Cleared Jan 10, 2014

ULTRASOUND SCANNER PRO FOCUS 2202

Radiology · 165d

Cleared Jan 07, 2014

ULTRASOUND SCANNER FLEX FOCUS 1202

Radiology · 132d

Cleared Jan 06, 2014

ULTRASOUND SCANNER PRO FOCUS 2202

Radiology · 131d

Cleared Feb 13, 2013

ULTRASOUND SCANNER FLEX FOCUS

Radiology · 118d

Cleared Dec 16, 2011

PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202

Radiology · 623d

Cleared Feb 02, 2009

NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336,...

Radiology · 53d

Cleared May 23, 2008

ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202

Radiology · 30d

Cleared Mar 05, 2007

ULTRASOUND SCANNER PROFOCUS, MODEL 2202

Radiology · 56d