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FDA 510(k)

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

K-Number: K912283 · 1992-03-16

ApplicantChalgren Enterprises, Inc.
Decision Date1992-03-16
Product CodeIKT
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Chalgren Enterprises, Inc.. It received FDA 510(k) clearance on 1992-03-16 under 510(k) number K912283. The device is classified under product code IKT. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1992-03-16. The listed applicant is Chalgren Enterprises, Inc.. The 510(k) number is K912283.

When did DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE receive FDA 510(k) clearance?

DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance on 1992-03-16, under 510(k) number K912283.

Who is the listed applicant for DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

The FDA 510(k) record lists Chalgren Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

The FDA product code for DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is IKT.

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Other records listing Chalgren Enterprises, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550K960591RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPK955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODEK953354EMG DISC RECORDING ELECTRODEK953361EMG DISC RECORDING ELECTRODEK953356EMG RECORDING RING ELECTRODE

View all 21 devices →

Related Devices (Code: IKT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)Technomed EuropeK173815Allergan Botox Needle ElectrodeNatus Manufacturing LimitedK161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing LimitedK152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLCK112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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