Medical Device Manufacturer · US , Sparks , NV

Bio Protech, Inc.

17 submissions · 17 cleared · Since 2002
17
Total
17
Cleared
0
Denied

Bio Protech, Inc. — FDA 510(k) Submissions

Bio Protech, Inc. has submitted 17 FDA 510(k) premarket notifications since 2002, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Electrocardiograph, Electrode, Cutaneous, Electrosurgical, Cutting & Coagulation & Accessories, Apparatus, Exhaust, Surgical, Stimulator, Nerve, Transcutaneous, For Pain Relief . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
EvaQMax Smoke Evacuation System
K192035 · FYD Apparatus, Exhaust, Surgical · General Hospital
Aug 2019 30d
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
K152984 · IKT Electrode, Needle,... · Neurology
Jun 2016 238d
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
K153019 · GXY Electrode, Cutaneous · Neurology
Mar 2016 158d
PROPENCIL Smoke Pencil
K143103 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jul 2015 260d
CUTANEOUS ELECTRODES
K142099 · GXY Electrode, Cutaneous · Neurology
Nov 2014 108d
REUSABLE STIMULATING ELECTRODES
K111270 · GXY Electrode, Cutaneous · Neurology
Sep 2011 133d
MAX-IF1000
K100246 · LIH Interferential Current... · Neurology
Nov 2010 301d
MAXEMS, MODELS 1000 AND 2000
K091248 · IPF Stimulator, Muscle, Powered · Physical Medicine
Nov 2009 216d
PROPENCIL ESU PENCIL
K092732 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2009 82d
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
K092761 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2009 76d
TELECTRODE WET GEL ECG ELECTRODE
K083148 · DRX Electrode,... · Cardiovascular
Nov 2008 14d
PROSTIM 1000/2000
K073438 · GZJ Stimulator, Nerve,... · Neurology
Feb 2008 62d
PROPLATE
K073360 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2007 19d
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
K053011 · DRX Electrode,... · Cardiovascular
Dec 2005 49d
PROTENS ELECTRODE
K042301 · GXY Electrode, Cutaneous · Neurology
Sep 2004 9d
PROTAB ECG TABB ELECTRODE
K040784 · DRX Electrode,... · Cardiovascular
Apr 2004 9d
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · DRX Electrode,... · Cardiovascular
Nov 2002 309d
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