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FDA 510(k)

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

K-Number: K032278 · 2004-03-05

ApplicantAmbu, Inc.
Decision Date2004-03-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K032278. 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 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE?

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Ambu, Inc.. The 510(k) number is K032278.

When did AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE receive FDA 510(k) clearance?

AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE received FDA 510(k) clearance on 2004-03-05, under 510(k) number K032278.

Who is the listed applicant for AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE?

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

What is the FDA product code for AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE?

The FDA product code for AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE is GXY.

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Other records listing Ambu, Inc. as applicant

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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.

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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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