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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKNElectromyograph, Diagnostic2Product Code
- IKTElectrode, Needle, Diagnostic Electromyograph2Product Code
- K173815Allergan Botox Needle Electrode2Cleared 510(K)
- K161430Myoject Luer Lock Needle Electrode2Cleared 510(K)
- K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes2Cleared 510(K)
- K143433Dantec 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-75mm2Cleared 510(K)
- K120342EMG RECORDING ELECTRODE ASSEMBLY2Cleared 510(K)
- K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLES2Cleared 510(K)
- K111131TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES2Cleared 510(K)
- K092973DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE2Cleared 510(K)
- K093825AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE2Cleared 510(K)
- K091410DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,2Cleared 510(K)
Show All 42 Submissions
- LYHArthrometer1Product Code
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K152984
- 510(k) Type
- Traditional
- Applicant
- BIO PROTECH, INC.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/3/2016
- Days to Decision
- 238 days
- Submission Type
- Summary