Medical Device Manufacturer · US , Mansfield , MA

Bio-Detek, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1985

Total

Cleared

Denied

Bio-Detek, Inc. has 17 FDA 510(k) cleared cardiovascular devices. Based in Mansfield, US.

Historical record: 17 cleared submissions from 1985 to 2015.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

Bio-Detek, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Bio-Detek, Inc.

17 devices

1-17 of 17

Cleared May 02, 2015

OneStep Pediatric CPR Multi-Function Electrode

K150055 · MKJ

Cardiovascular · 110d

Cleared May 02, 2015

CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

K150198 · MKJ

Cardiovascular · 93d

Cleared Oct 10, 2014

ONESTEP CPR II MULTI-FUNCTION ELECTRODE

K133441 · MKJ

Cardiovascular · 332d

Cleared Nov 16, 2010

DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL...

K100565 · MKJ

Cardiovascular · 260d

Cleared Sep 12, 2007

POCKETCPR

K071321 · LIX

Cardiovascular · 125d

Cleared Apr 09, 2004

BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90

K040056 · MKJ

Cardiovascular · 87d

Cleared Apr 09, 2004

PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005

K040256 · MKJ

Cardiovascular · 65d

Cleared Feb 27, 2004

BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR

K033771 · MKJ

Cardiovascular · 86d

Cleared Mar 16, 1999

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

K984582 · MKJ

Cardiovascular · 83d

Cleared Feb 26, 1999

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES

K990106 · MKJ

Cardiovascular · 45d

Cleared Nov 25, 1998

ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003

K981802 · MKJ

Cardiovascular · 188d

Cleared Nov 25, 1996

TRACE RITE SOLID GEL ECG ELECTRODES

K964213 · DRX

Cardiovascular · 34d

Cleared Aug 14, 1992

BIO-DETEK EEG ELECTRODE

K920352 · GXZ

Neurology · 200d

Cleared Jun 02, 1992

BIO-DETEK TRACERITE EEG ELECTRODE

K920264 · GXY

Neurology · 133d

Cleared Jul 25, 1991

RT40 RADIO TRANSLUCENT

K912714 · DRX

Cardiovascular · 37d

Cleared Jan 07, 1986

DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODES

K853038 · DRX

Cardiovascular · 172d

Cleared Oct 10, 1985

GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300

K853291 · HAM

General & Plastic Surgery · 66d

Bio-Detek, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Bio-Detek, Inc.

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