Medical Device Manufacturer · US , Sparks , NV

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

17 submissions · 17 cleared · Since 2002

Recent clearances: EvaQMax Smoke Evacuation System

17
Total
17
Cleared
0
Denied

Bio Protech, Inc. has 17 FDA 510(k) cleared medical devices. Based in Sparks, US.

Historical record: 17 cleared submissions from 2002 to 2019. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Bio Protech, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

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

17 devices
1-17 of 17
Cleared Aug 29, 2019
EvaQMax Smoke Evacuation System
K192035 · FYD
General Hospital · 30d
Cleared Jun 03, 2016
Disposable Concentric Needle electrodes, Disposable Monopolar Needle...
K152984 · IKT
Neurology · 238d
Cleared Mar 21, 2016
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
K153019 · GXY
Neurology · 158d
Cleared Jul 16, 2015
PROPENCIL Smoke Pencil
K143103 · GEI
General & Plastic Surgery · 260d
Cleared Nov 17, 2014
CUTANEOUS ELECTRODES
K142099 · GXY
Neurology · 108d
Cleared Sep 13, 2011
REUSABLE STIMULATING ELECTRODES
K111270 · GXY
Neurology · 133d
Cleared Nov 24, 2010
MAX-IF1000
K100246 · LIH
Neurology · 301d
Cleared Nov 30, 2009
MAXEMS, MODELS 1000 AND 2000
K091248 · IPF
Physical Medicine · 216d
Cleared Nov 25, 2009
PROPENCIL ESU PENCIL
K092732 · GEI
General & Plastic Surgery · 82d
Cleared Nov 24, 2009
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
K092761 · GEI
General & Plastic Surgery · 76d
Cleared Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
K083148 · DRX
Cardiovascular · 14d
Cleared Feb 07, 2008
PROSTIM 1000/2000
K073438 · GZJ
Neurology · 62d
Cleared Dec 19, 2007
PROPLATE
K073360 · GEI
General & Plastic Surgery · 19d
Cleared Dec 14, 2005
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
K053011 · DRX
Cardiovascular · 49d
Cleared Sep 03, 2004
PROTENS ELECTRODE
K042301 · GXY
Neurology · 9d
Cleared Apr 07, 2004
PROTAB ECG TABB ELECTRODE
K040784 · DRX
Cardiovascular · 9d
Cleared Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
K020003 · DRX
Cardiovascular · 309d
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