FDA 510(k) Applications Submitted by Bio Protech, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K152984 |
10/09/2015 |
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes |
BIO PROTECH, INC. |
| K153019 |
10/15/2015 |
Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes |
BIO PROTECH, INC. |
| K042301 |
08/25/2004 |
PROTENS ELECTRODE |
BIO PROTECH, INC. |
| K040784 |
03/29/2004 |
PROTAB ECG TABB ELECTRODE |
BIO PROTECH, INC. |
| K053011 |
10/26/2005 |
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 |
BIO PROTECH, INC. |
| K073360 |
11/30/2007 |
PROPLATE |
BIO PROTECH, INC. |
| K073438 |
12/07/2007 |
PROSTIM 1000/2000 |
BIO PROTECH, INC. |
| K020003 |
01/02/2002 |
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE |
BIO PROTECH, INC. |
| K100246 |
01/27/2010 |
MAX-IF1000 |
BIO PROTECH, INC. |
| K091248 |
04/28/2009 |
MAXEMS, MODELS 1000 AND 2000 |
BIO PROTECH, INC. |
| K111270 |
05/03/2011 |
REUSABLE STIMULATING ELECTRODES |
BIO PROTECH, INC. |
| K092761 |
09/09/2009 |
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C |
BIO PROTECH, INC. |
| K092732 |
09/04/2009 |
PROPENCIL ESU PENCIL |
BIO PROTECH, INC. |
| K083148 |
10/24/2008 |
TELECTRODE WET GEL ECG ELECTRODE |
BIO PROTECH, INC. |
| K192035 |
07/30/2019 |
EvaQMax Smoke Evacuation System |
Bio Protech, Inc. |
| K142099 |
08/01/2014 |
CUTANEOUS ELECTRODES |
BIO PROTECH, INC. |
| K143103 |
10/29/2014 |
PROPENCIL Smoke Pencil |
BIO PROTECH, INC. |
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