BIO-DETEK, INC.

Matched from indexed company URL: Bio-Detek, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12180581218058BIO-DETEK, INC.1N2020-04-25525 Narragansett Park Dr PAWTUCKET RI US 02861

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
299961952069935K984582ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXXMKJ1999-03-16
299961509635764K981802ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003MKJ1998-11-25
299961871097209K964213TRACE RITE SOLID GEL ECG ELECTRODESDRX1996-11-25
299961629984444K960676ZOLL STATPADZ RADIOLUCENT ADULT MULTI-FUCTION ELECTRODES MODEL 8900-4004DTE1996-06-05
299961085070048K943698STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODESMKJ1994-12-28
299961028881872K931804ZOLL D 5400 ADULT SOLID GEL DEFIBRILLATION ELECTROLDD1993-10-08
299961983281326K9318035200 ADULT SOLID GEL MULTI-FUNCTION ELECTRODESLDD1993-10-08
299961391724569K931787ZOLL PD 5300LDD1993-10-15
299961920378194K915159PEDIATRIC MULTI-FUNCTION ELECTRODESDRF1992-02-07
299961559428801K912714RT40 RADIO TRANSLUCENTDRX1991-07-25
299961926257309K895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODESLDD1989-10-12
299961465355438K885166ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODESDRO1989-05-01
299961006462305K844856ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NONDRX1985-02-20
299961852343431K841944DISPOSABLE ECG ELECTRODEDRX1985-03-01
299961518172443K840353PACEMAKER PULSE GENERATOR W/ELECTRODEDRO1984-04-23
299961751897377K790305ELECTRODES, FERRIS ECG, TYPES 905,906DRX1979-04-03
299961286456423K150198CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz GelMKJ2015-05-02
299961492905985K150055OneStep Pediatric CPR Multi-Function ElectrodeMKJ2015-05-02
299961878499272K133441ONESTEP CPR II MULTI-FUNCTION ELECTRODEMKJ2014-10-10
299961766302939K120907ZOLL R SERIESMKJ2012-09-25
299961270131515K112660POCKETCPRLIX2012-05-10
299961461099123K111473UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATORCBK2012-02-16
299961506841863K110978ONESTEP PEDIATRIC MFE'SMKJ2011-05-13
299962039335318K110742ONESTEP ADULT MULTI-FUNCTION ELECTRODEMKJ2011-04-13
299961309480699K100565DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325MKJ2010-11-16
299962008989008K072430ZOLL PEDIPADZ REDUCED ENERGY ELECTRODEMKJ2007-11-06
299961668674609K040256PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005MKJ2004-04-09
299961052153111K040056BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90MKJ2004-04-09
299961542035150K033771BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTORMKJ2004-02-27
299962032245106K033474ZOLL AED PLUSMKJ2004-05-21
299961657426451K011541ZOLL PAD WITH CPR AIDMKJ2002-04-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MKJ162015-05-02
DRX51996-11-25
LDD41993-10-15
DRO21989-05-01
LIX12012-05-10
CBK12012-02-16
DTE11996-06-05
DRF11992-02-07

PMN#