FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K022023 |
CLINICAL INNOVATIONS, INC. |
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 |
01/07/2003 |
K983665 |
DENTSLEEVE PTY., LTD. |
MANOMETRIC ASSEMBLIES |
05/17/1999 |
K954798 |
KAY ELEMETRICS CORP. |
7100 SWALLOWING WORKSTATION |
06/04/1996 |
K013704 |
MEDIPLUS LTD. |
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER |
08/05/2002 |
K031617 |
MEDIPLUS LTD. |
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER |
01/16/2004 |
K120088 |
MEDSPIRA, LLC |
MCOMPASS ANORECTAL MANOMETRY SYSTEM |
03/29/2012 |
K143031 |
MEDSPIRA, LLC |
mcompass Biofeedback Anorectal Manometry System |
07/07/2015 |
K032138 |
MEDTRONIC VASCULAR |
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER |
10/09/2003 |
K964589 |
OAKFIELD INSTRUMENTS, LTD. |
FLEXILOG 3000 |
03/04/1997 |
K964804 |
OAKFIELD INSTRUMENTS, LTD. |
FLEXILOG LS |
08/06/1997 |
K961895 |
OAKFIELD INSTRUMENTS, LTD. |
FLEXILOG LS 13921 |
11/04/1996 |
K961056 |
SANDHILL SCIENTIFIC, INC. |
BIOVIEW MODEL S960000 |
06/06/1996 |
K062362 |
SARMED SRL |
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS |
04/13/2007 |
K961070 |
SYNECTICS MEDICAL, INC. |
ESOPHAGEAL MANOMETRY ANALYSIS MODULE |
06/11/1996 |
K161785 |
THD SPA |
THD ANOPRESS |
03/14/2017 |
K180135 |
THD SpA |
THD Anopress with THD SensyProbe |
03/08/2018 |