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Bio-Detek, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K100565 DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325MKJ2010-11-16 View
510(k) K071321 POCKETCPRLIX2007-09-12 View
510(k) K040056 BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90MKJ2004-04-09 View
510(k) K040256 PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005MKJ2004-04-09 View
510(k) K033771 BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTORMKJ2004-02-27 View
510(k) K984582 ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXXMKJ1999-03-16 View
510(k) K990106 ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODESMKJ1999-02-26 View
510(k) K981802 ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003MKJ1998-11-25 View
510(k) K964213 TRACE RITE SOLID GEL ECG ELECTRODESDRX1996-11-25 View
510(k) K920352 BIO-DETEK EEG ELECTRODEGXZ1992-08-14 View
510(k) K920264 BIO-DETEK TRACERITE EEG ELECTRODEGXY1992-06-02 View
510(k) K912714 RT40 RADIO TRANSLUCENTDRX1991-07-25 View
510(k) K853038 DE12 RAPID TRACE AT-REST DIAGNOSTIC ECG ELECTRODESDRX1986-01-07 View
510(k) K853291 GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300HAM1985-10-10 View
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