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FDA 510(k)

NEUROLOGICAL DIAGNOSTIC DEVICES

K-Number: K943449 · 1995-11-15

ApplicantHenley Intl.
Decision Date1995-11-15
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLOGICAL DIAGNOSTIC DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1995-11-15 under 510(k) number K943449. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROLOGICAL DIAGNOSTIC DEVICES?

NEUROLOGICAL DIAGNOSTIC DEVICES is a medical device that received FDA 510(k) clearance on 1995-11-15. The listed applicant is Henley Intl.. The 510(k) number is K943449.

When did NEUROLOGICAL DIAGNOSTIC DEVICES receive FDA 510(k) clearance?

NEUROLOGICAL DIAGNOSTIC DEVICES received FDA 510(k) clearance on 1995-11-15, under 510(k) number K943449.

Who is the listed applicant for NEUROLOGICAL DIAGNOSTIC DEVICES?

The FDA 510(k) record lists Henley Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROLOGICAL DIAGNOSTIC DEVICES?

The FDA product code for NEUROLOGICAL DIAGNOSTIC DEVICES is GXY.

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Other records listing Henley Intl. 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.

K926279UPPER BODY EXERCISERK926278STAIR CLIMBERK926287EXERCISE BICYCLEK926314HYDRA FITNESS MODEL 311 TOTAL POWERK926313COMPUTERIZED TESTING AND EXERCISE SYSTEMSK915864MONOTRODE CUTANEOUS ELECTRODE

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Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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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