Bio Protech, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EvaQMax Smoke Evacuation System, Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes, Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bio Protech, Inc. Cardiovascular ✕
4 devices
Cleared
Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
Cardiovascular
14d
Cleared
Dec 14, 2005
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
Cardiovascular
49d
Cleared
Apr 07, 2004
PROTAB ECG TABB ELECTRODE
Cardiovascular
9d
Cleared
Nov 07, 2002
ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
Cardiovascular
309d