Medical Device Manufacturer · DK , Skovlunde

Medtronic Functional Diagnostics A/S - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1999

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Medtronic Functional Diagnostics A/S Gastroenterology & Urology ✕

9 devices

1-9 of 9

Cleared Nov 21, 2002

POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151

Gastroenterology & Urology · 329d

Cleared Nov 08, 2002

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER...

Gastroenterology & Urology · 543d

Cleared Aug 10, 2001

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL...

Gastroenterology & Urology · 88d

Cleared Feb 07, 2001

POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103

Gastroenterology & Urology · 22d

Cleared May 05, 2000

POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

Gastroenterology & Urology · 88d

Cleared Feb 28, 2000

NEURO URODYNAMIC SUITE, MODEL 9032E0101

Gastroenterology & Urology · 200d

Cleared Nov 10, 1999

POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS...

Gastroenterology & Urology · 90d

Cleared Jul 15, 1999

ANORECTAL MANOMETRY SUITE, MODEL 9032S0201

Gastroenterology & Urology · 85d

Cleared Feb 04, 1999

DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111

Gastroenterology & Urology · 262d