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FDA 510(k)

Grass® MR Conditional/CT Cup Electrodes

K-Number: K242346 · 2024-08-29

ApplicantNatus Manufacturing Limited
Decision Date2024-08-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Grass® MR Conditional/CT Cup Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Natus Manufacturing Limited. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K242346. 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 Grass® MR Conditional/CT Cup Electrodes?

Grass® MR Conditional/CT Cup Electrodes is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Natus Manufacturing Limited. The 510(k) number is K242346.

When did Grass® MR Conditional/CT Cup Electrodes receive FDA 510(k) clearance?

Grass® MR Conditional/CT Cup Electrodes received FDA 510(k) clearance on 2024-08-29, under 510(k) number K242346.

Who is the listed applicant for Grass® MR Conditional/CT Cup Electrodes?

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

What is the FDA product code for Grass® MR Conditional/CT Cup Electrodes?

The FDA product code for Grass® MR Conditional/CT Cup Electrodes is GXY.

Other records listing Natus Manufacturing Limited 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.

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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.

K260578Ambu® 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 EuropeK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., 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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