FDA 510(k)

PROTECTRODE SYSTEMS CONCENTRIC

K-Number: K932691 · 1995-11-16

Decision Date1995-11-16

Product CodeIKT

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

PROTECTRODE SYSTEMS CONCENTRIC is the device name listed in this FDA 510(k) record. The listed applicant is The Electrode Store, Inc.. It received FDA 510(k) clearance on 1995-11-16 under 510(k) number K932691. 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 PROTECTRODE SYSTEMS CONCENTRIC?

PROTECTRODE SYSTEMS CONCENTRIC is a medical device that received FDA 510(k) clearance on 1995-11-16. The listed applicant is The Electrode Store, Inc.. The 510(k) number is K932691.

When did PROTECTRODE SYSTEMS CONCENTRIC receive FDA 510(k) clearance?

PROTECTRODE SYSTEMS CONCENTRIC received FDA 510(k) clearance on 1995-11-16, under 510(k) number K932691.

Who is the listed applicant for PROTECTRODE SYSTEMS CONCENTRIC?

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

What is the FDA product code for PROTECTRODE SYSTEMS CONCENTRIC?

The FDA product code for PROTECTRODE SYSTEMS CONCENTRIC is IKT.

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Other records listing The Electrode Store, Inc. as applicant

K083758SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS K022197SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY K020910SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF K020445THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG K926094PROTECTRODE SYSTEM

Related Devices (Code: IKT)

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 Europe K173815Allergan Botox Needle ElectrodeNatus Manufacturing Limited K161430Myoject Luer Lock Needle ElectrodeNatus Manufacturing Limited K152984Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodesBio Protech, Inc.K120342EMG RECORDING ELECTRODE ASSEMBLYRhythmlink International, LLC K112034TECA ELITE DISPOSABLE CONCENTRIC NEEDLESCarefusion 209, Inc.

Official Source

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