FDA.reportPublic FDA data

510(k) K040056

Device
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
Applicant
Bio-Detek, Inc.
510(k) number
K040056
Product code
MKJ
Decision
Substantially Equivalent (SESE)
Decision date
2004-04-09
Date received
2004-01-13
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
Summary
Third party reviewed
N

Applicant Contact#

Contact
ROBERT MORSE
Address
525 Narragansett Park Dr. Pawtucket RI US 02861 02861

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MKJ#

510(k), Device, Applicant table
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K150055OneStep Pediatric CPR Multi-Function ElectrodeBio-Detek, Inc.2015-05-02
K142709samaritan PAD 450PHeartsine Technologies, Inc.2015-03-27
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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