Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes— 510(k) K152984
Substantially EquivalentBio Protech, Inc.
FDA 510(k) clearance K152984 for Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes, Substantially Equivalent on 2016-06-03. Applicant: Bio Protech, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Protech, Inc.
- Product code
- Code IKT
- Device class
- Class 2
- Regulation
- 21 CFR 890.1385
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wonju-Si, KR
Recent devices under product code IKT
view all- K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) +5 more
- K173815 — Allergan Botox Needle Electrode
- K161430 — Myoject Luer Lock Needle Electrode
- K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
- K120342 — EMG RECORDING ELECTRODE ASSEMBLY
More clearances from Bio Protech, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.