FDA.reportPublic FDA data

510(k) K002079

Device
MULTI-FUNCTION DEFIBRILLATION ELECTRODE
Applicant
Medicotest A/S
510(k) number
K002079
Product code
MKJ
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-22
Date received
2000-07-10
Regulation
870.5310
Classification name
Automated External Defibrillators (Non-Wearable)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
EMALEE G MURPHY
Address
1900 K St. NW Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MKJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143714Powerheart G5 AEDCardiac Science Corporation2015-05-04
K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelBio-Detek, Inc.2015-05-02
K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.2015-05-02
K142709samaritan PAD 450PHeartsine Technologies, Inc.2015-03-27
K133659HEARTSTART XL+DEFIBRILLATOR/MONITOR WITH END-TIDAL CARBON DIOXIDE MONITORINGPhilips Medical Systems2015-01-23
K133239ZOLL E SERIESZoll Medical Corporation, World Wide Headquarters2015-01-16
K142430LIFEPAK 15 monitor/defibrillatorPhysio-Control, Inc.2014-12-19
K141795BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500R & D Batteries, Inc.2014-12-08
K142915ZOLL X SeriesZOLL Medical Corporation2014-12-03
K142803Skintact, various other tradenamesLeonhard Lang GmbH2014-12-02
K141231ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERYZeller Power Products (Battery Beast, LLC)2014-11-25
K141774ZOLL X SERIESZOLL Medical Corporation2014-11-19
K133441ONESTEP CPR II MULTI-FUNCTION ELECTRODEBio-Detek, Inc.2014-10-10
K133484ZOLL X SERIESZoll Medical Corp2014-08-01
K133269ZOLL X SERIESZoll Medical Corporation, World Wide Headquarters2014-05-22