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FDA 510(k)

AMBU NEUROLINE GROUND

K-Number: K051529 · 2005-08-04

ApplicantAmbu, Inc.
Decision Date2005-08-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMBU NEUROLINE GROUND is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 2005-08-04 under 510(k) number K051529. 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 GROUND?

AMBU NEUROLINE GROUND is a medical device that received FDA 510(k) clearance on 2005-08-04. The listed applicant is Ambu, Inc.. The 510(k) number is K051529.

When did AMBU NEUROLINE GROUND receive FDA 510(k) clearance?

AMBU NEUROLINE GROUND received FDA 510(k) clearance on 2005-08-04, under 510(k) number K051529.

Who is the listed applicant for AMBU NEUROLINE GROUND?

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 GROUND?

The FDA product code for AMBU NEUROLINE GROUND is GXY.

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Other records listing Ambu, Inc. 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.

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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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