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510(k) K934434

Device
CYBERRX MODEL 7200
Applicant
CYBERMED CONTROL SYSTEMS, INC.
510(k) number
K934434
Product code
FFT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-01-24
Date received
1993-08-23
Regulation
876.1400
Classification name
Electrode, Ph, Stomach
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL S GOLDBERG
Address
12770 High Bluff Dr. Suite 180 San Diego CA US 92130 92130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FFT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESGiven Imaging , Ltd.2010-12-01
K013951SANDHILL SCIENTIFIC PEDIATEC PH PROBESandhill Scientific, Inc.2002-02-28
K002028BRAVO PH MONITORING SYSTEMEndonetics, Inc.2000-09-29
K961346PH ANALYSIS MODULESynectics-Dantec1997-01-29
K950087LOT 440Medical Instruments Corporation Mic AG1996-02-06
K955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORInstrumentarium Corp.1996-01-30
K945069FLEXILOG 2000Oakfield Instruments, Ltd.1995-06-13
K920849TRIP CIC CATHETERTonometrics, Inc.1995-03-17
K925405ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.Synectics-Dantec1994-09-30
K931963SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBESandhill Scientific, Inc.1994-09-28
K913817MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATIONSynectics-Dantec1992-06-11
K914624PH METER, MODIFICATIONSynectics-Dantec1992-04-28
K912772SUPERLOGGERSandhill Scientific, Inc.1992-02-07
K913387DIGITRAPPER MARK IIISynectics-Dantec1991-12-27
K911825TRIP(TM) NASOGASTRIC SUMP CATHETERTonometrics, Inc.1991-07-23

Legacy Summary#

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FDA Review#

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