Anesthesiology
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- ChemistryReview Panel
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- Gastroenterology and UrologyReview Panel
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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)
- K091055RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R2Cleared 510(K)
- K091056RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R2Cleared 510(K)
- K080914ULTRASHARP CONCENTRIC NEEDLES2Cleared 510(K)
- K071186MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE2Cleared 510(K)
- K062437DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED2Cleared 510(K)
- K020907NEUROLINE, SUBDERMAL NEEDLE ELECTRODES2Cleared 510(K)
- K011818STERILE EMG ELECTRODES2Cleared 510(K)
- K002992DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S04312Cleared 510(K)
- K001869DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE2Cleared 510(K)
- K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-5502Cleared 510(K)
- K990015ELECTRODE NEEDLES2Cleared 510(K)
- K990375DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 752Cleared 510(K)
- K981004SLE EMG ELECTRODES AND ACCESSORIES2Cleared 510(K)
- K973529NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES2Cleared 510(K)
- K973442TECA DISPOSABLE MONOPOLAR NEEDLE ELECTRODES2Cleared 510(K)
- K973444TECA MYOJECT DISPOSABLE NEEDLE ELECTRODES2Cleared 510(K)
- K961013DISPOSABLE NEEDLE ELECTRODE2Cleared 510(K)
- K960591RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP2Cleared 510(K)
- K955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE2Cleared 510(K)
- K932691PROTECTRODE SYSTEMS CONCENTRIC2Cleared 510(K)
- K953886RE-USABLE MONOPOLAR NEEDLE2Cleared 510(K)
- K953887RE-USABLE CONCENTRIC NEEDLE2Cleared 510(K)
- K932059NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE2Cleared 510(K)
- K931029DISPOSABLE CONCENTRIC NEEDLE ELECTRODE2Cleared 510(K)
- K931966DANTEC DISPOSABLE CONCENTRIC NEEDLE2Cleared 510(K)
- K924521DISPOSABLE CONCENTRIC NEEDLE ELECTRODE2Cleared 510(K)
- K912282DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS2Cleared 510(K)
- K912283DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE2Cleared 510(K)
- K896874DANTEC ELECTRODES MODEL DNE 116, 117 & 13P02/122Cleared 510(K)
- K895460CONCENTRIC ELECTRODE TYPE #13R01, 13R022Cleared 510(K)
- K870795EMG ELECTRODES AND EXTENSION CORDS2Cleared 510(K)
- K854664MEB-52002Cleared 510(K)
- 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
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ULTRASHARP CONCENTRIC NEEDLES
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K080914
- 510(k) Type
- Abbreviated
- Applicant
- Rochester Electro Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/15/2008
- Days to Decision
- 105 days
- Submission Type
- Summary