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FDA 510(k)

NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM

K-Number: K042384 · 2005-03-29

ApplicantCyberkinetics, Inc. (Cki)
Decision Date2005-03-29
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cyberkinetics, Inc. (Cki). It received FDA 510(k) clearance on 2005-03-29 under 510(k) number K042384. 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 NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM?

NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-29. The listed applicant is Cyberkinetics, Inc. (Cki). The 510(k) number is K042384.

When did NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM receive FDA 510(k) clearance?

NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM received FDA 510(k) clearance on 2005-03-29, under 510(k) number K042384.

Who is the listed applicant for NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM?

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

What is the FDA product code for NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM?

The FDA product code for NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM is GZL.

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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

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

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