Home / Device Classification / FFT

FFT — Electrode, Ph, Stomach Class I

FDA Device Classification

Classification Details

Product Code
FFT
Device Class
Class I
Regulation Number
876.1400
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K102543given imagingBRAVO PH MONITORING SYSTEM AND ACCESSORIESDecember 1, 2010
K013951sandhill scientificSANDHILL SCIENTIFIC PEDIATEC PH PROBEFebruary 28, 2002
K002028endoneticsBRAVO PH MONITORING SYSTEMSeptember 29, 2000
K961346synectics-dantecPH ANALYSIS MODULEJanuary 29, 1997
K950087medical instruments corporation micLOT 440February 6, 1996
K955018instrumentariumTRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORJanuary 30, 1996
K945069oakfield instrumentsFLEXILOG 2000June 13, 1995
K920849tonometricsTRIP CIC CATHETERMarch 17, 1995
K934434cybermed control systemsCYBERRX MODEL 7200January 24, 1995
K925405synectics-dantecZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.September 30, 1994
K931963sandhill scientificSANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBESeptember 28, 1994
K913817synectics-dantecMONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATIONJune 11, 1992
K914624synectics-dantecPH METER, MODIFICATIONApril 28, 1992
K912772sandhill scientificSUPERLOGGERFebruary 7, 1992
K913387synectics-dantecDIGITRAPPER MARK IIIDecember 27, 1991
K911825tonometricsTRIP(TM) NASOGASTRIC SUMP CATHETERJuly 23, 1991
K910694zinetics medicalZINETICS INTERNAL REFERENCE PROBEMay 17, 1991
K903646medics instrumentGASTROGRAPHNovember 5, 1990
K902366synectics-dantecMODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNITJune 8, 1990
K896288oakfield instrumentsFLEXILOG 1010 AMBULATORY PH MONITORING SYSTEMMay 4, 1990