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510(k) K842312

Device
SERVOCARD SCP-840
Applicant
LITTON DATAMEDIX
510(k) number
K842312
Product code
LDD  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-27
Date received
1984-06-12
Regulation
870.5300
Classification name
Dc-defibrillator, Low-energy, (including Paddles)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID O JONES
Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203231Switched Internal PaddlesPhilips North America, LLC2021-01-11
K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company2020-07-24
K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.2019-06-03
K150349Rapid Hair Removal PadsFull Power Aed2015-07-14
K140502ZOLL E SERIES ALSZOLL Medical Corporation2014-11-06
K103651CARDIOMEDCardio Medical Products, Inc.2011-10-04
K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab Spa2011-06-16
K103334CARDIO MEDCardio Medical Products, Inc.2011-01-18
K103159CARDIO MED MODEL A102, H104, O101, P103, AND Z100Cardio Medical Products, Inc.2011-01-11
K102468ZOLL PROPAQ MDZoll Medical Corporation, World Wide Headquarters2010-09-30
K100654ZOLL PROPAQ MDZoll Medical Corporation, World Wide Headquarters2010-07-29
K081442HEART SYNC PEDIATRIC, MODEL PED-100Heart Sync, LLC2008-09-24
K081574ZOLL R SERIESZOLL Medical Corporation2008-09-18
K042302ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLEZoll Medical Corp2004-10-26
K032691ZOLL AUTOCLAVABLE INTERNAL HANDLESZoll Medical Corp2003-11-13

Legacy Summary#

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FDA Review#

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