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FDA 510(k)

MODIFICATION TO GALILEO GOLD

K-Number: K080181 · 2008-06-24

ApplicantHamilton Medical AG
Decision Date2008-06-24
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO GALILEO GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical AG. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K080181. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO GALILEO GOLD?

MODIFICATION TO GALILEO GOLD is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Hamilton Medical AG. The 510(k) number is K080181.

When did MODIFICATION TO GALILEO GOLD receive FDA 510(k) clearance?

MODIFICATION TO GALILEO GOLD received FDA 510(k) clearance on 2008-06-24, under 510(k) number K080181.

Who is the listed applicant for MODIFICATION TO GALILEO GOLD?

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

What is the FDA product code for MODIFICATION TO GALILEO GOLD?

The FDA product code for MODIFICATION TO GALILEO GOLD is CBK.

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Other records listing Hamilton Medical AG 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.

K201306HAMILTON-C3K201658Hamilton-C6K193228Hamilton-G5K181216HAMILTON-T1, HAMILTON-C1K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010K161450HAMILTON-C3

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Related Devices (Code: CBK)

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.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics 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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