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FDA 510(k)

RECORDING AND STIMULATING ELECTRODE

K-Number: K012850 · 2001-11-19

ApplicantRadionics, A Division of Tyco Healthcare Group LP
Decision Date2001-11-19
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RECORDING AND STIMULATING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2001-11-19 under 510(k) number K012850. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECORDING AND STIMULATING ELECTRODE?

RECORDING AND STIMULATING ELECTRODE is a medical device that received FDA 510(k) clearance on 2001-11-19. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. The 510(k) number is K012850.

When did RECORDING AND STIMULATING ELECTRODE receive FDA 510(k) clearance?

RECORDING AND STIMULATING ELECTRODE received FDA 510(k) clearance on 2001-11-19, under 510(k) number K012850.

Who is the listed applicant for RECORDING AND STIMULATING ELECTRODE?

The FDA 510(k) record lists Radionics, A Division of Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RECORDING AND STIMULATING ELECTRODE?

The FDA product code for RECORDING AND STIMULATING ELECTRODE is GZL.

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Other records listing Radionics, A Division of Tyco Healthcare Group LP as applicant

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Related Devices (Code: GZL)

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.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.

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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