Medical Device Manufacturer · DK , Dk 2820 Gentofte

B & K Medical A/S - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1995

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - B & K Medical A/S Radiology ✕

11 devices

1-11 of 11

Cleared Jan 14, 2005

ULTRASOUND SCANNER MINI FOCUS, MODEL 1402

Radiology · 18d

Cleared Jan 13, 2005

ULTRASOUND SCANNER PRO FOCUS, MODEL 2202

Radiology · 24d

Cleared Jan 17, 2003

ULTRASOUND SCANNER, TYPE 2400

Radiology · 25d

Cleared Nov 01, 2002

ULTRASOUND SCANNER, TYPE 1101

Radiology · 17d

Cleared Jun 08, 2001

ULTRASOUND SCANNER, TYPE 2102

Radiology · 30d

Cleared Apr 03, 2001

ULTRASOUND SCANNER TYPE 2102

Radiology · 98d

Cleared Feb 07, 2001

ULTRASOUND SCANNER TYPE 2101

Radiology · 131d

Cleared Aug 01, 2000

ULTRASOUND SCANNER, TYPE 1101

Radiology · 22d

Cleared Mar 09, 2000

ULTRASOUND SCANNER TYPE 2102

Radiology · 16d

Cleared Jul 30, 1999

ULTRASOUND SCANNER, MODEL TYPE 2101

Radiology · 51d

Cleared Aug 22, 1995

ULTRASOUND SCANNER 2001

Radiology · 613d