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510(k) K963787

Device
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
Applicant
CONMED CORP.
510(k) number
K963787
Product code
DRX  
Decision
Substantially Equivalent (SESE)
Decision date
1997-03-11
Date received
1996-09-20
Regulation
870.2360
Classification name
Electrode, Electrocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
IRA D DUESLER, JR.
Address
310 Broad St. Utica NY US 13501 13501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171244PhysiotraceNimbleheart, Inc.2017-08-23
K140096HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGEHmicro, Inc.2014-07-24
K123658BIOMODULE 3-M1Zephyr Technology Corporation2013-04-24
K101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.2010-07-22
K101685IP-SETIntegral Process Sas2010-07-01
K100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/S2010-06-11
K093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.2010-05-10
K10031512 LEAD GLOVEI Needmd, Inc.2010-04-23
K092744NEONATAL ECG ELECTRODE, M203KENR & D Medical Products, Inc.2009-12-10
K092389DISPOSAL ECG ELECTRODES, MODEL EASYRODESuzuken Co., Ltd.2009-10-13
K090496QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCHCardiac Lead Technologies, Inc.2009-09-01
K092291SKINTACT AND VARIOUS OTHER TRADENAMESLeonhard Lang GmbH2009-08-21
K091856CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIESConmed Corporation2009-08-07
K090180TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODEVermed, Inc.2009-06-17
K083677PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1Commwell , Ltd.2009-03-10

Legacy Summary#

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FDA Review#

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