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510(k) K053011

Device
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
Applicant
BIO PROTECH, INC.
510(k) number
K053011
Product code
DRX  
Decision
Substantially Equivalent (SESE)
Decision date
2005-12-14
Date received
2005-10-26
Regulation
870.2360
Classification name
Electrode, Electrocardiograph
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
E.J. Smith
Address
1676 Village Green Suite A Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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#

summary

FDA Review#

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