FDA 510(k) Applications Submitted by BIO-DETEK, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150055 |
01/12/2015 |
OneStep Pediatric CPR Multi-Function Electrode |
BIO-DETEK, INC. |
| K150198 |
01/29/2015 |
CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel |
Bio-Detek, Inc. |
| K071321 |
05/10/2007 |
POCKETCPR |
BIO-DETEK, INC. |
| K990106 |
01/12/1999 |
ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES |
BIO-DETEK, INC. |
| K981802 |
05/21/1998 |
ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 |
BIO-DETEK, INC. |
| K964213 |
10/22/1996 |
TRACE RITE SOLID GEL ECG ELECTRODES |
BIO-DETEK, INC. |
| K984582 |
12/23/1998 |
ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX |
BIO-DETEK, INC. |
| K040056 |
01/13/2004 |
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 |
BIO-DETEK, INC. |
| K040256 |
02/04/2004 |
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 |
BIO-DETEK, INC. |
| K100565 |
03/01/2010 |
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 |
BIO-DETEK, INC. |
| K033771 |
12/03/2003 |
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR |
BIO-DETEK, INC. |
| K133441 |
11/12/2013 |
ONESTEP CPR II MULTI-FUNCTION ELECTRODE |
BIO-DETEK, INC. |
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