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Bio Protech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K192035EvaQMax Smoke Evacuation SystemAugust 29, 2019
K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP NeedlJune 3, 2016
K153019Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup ElectrodesMarch 21, 2016
K143103PROPENCIL Smoke PencilJuly 16, 2015
K142099CUTANEOUS ELECTRODESNovember 17, 2014
K111270REUSABLE STIMULATING ELECTRODESSeptember 13, 2011
K100246MAX-IF1000November 24, 2010
K091248MAXEMS, MODELS 1000 AND 2000November 30, 2009
K092732PROPENCIL ESU PENCILNovember 25, 2009
K092761PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642CNovember 24, 2009
K083148TELECTRODE WET GEL ECG ELECTRODENovember 7, 2008
K073438PROSTIM 1000/2000February 7, 2008
K073360PROPLATEDecember 19, 2007
K053011PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20December 14, 2005
K042301PROTENS ELECTRODESeptember 3, 2004
K040784PROTAB ECG TABB ELECTRODEApril 7, 2004
K020003ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILENovember 7, 2002