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510(k) K042302

Device
ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTEGRATED ELECTRODES, ZOLL AUTOCLAVABLE
Applicant
ZOLL MEDICAL CORP.
510(k) number
K042302
Product code
LDD  
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-26
Date received
2004-08-25
Regulation
870.5300
Classification name
Dc-defibrillator, Low-energy, (including Paddles)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SEAN REYNOLDS
Address
269 Mill Rd. Chelsmford MA US 01824 01824

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
K032691ZOLL AUTOCLAVABLE INTERNAL HANDLESZoll Medical Corp2003-11-13
K030417DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLESPhilips Medical Systems2003-05-09

Legacy Summary#

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FDA Review#

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