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FDA 510(k)

GALILEO GOLD

K-Number: K040574 · 2004-10-27

ApplicantHamilton Medical, Inc.
Decision Date2004-10-27
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GALILEO GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Medical, Inc.. It received FDA 510(k) clearance on 2004-10-27 under 510(k) number K040574. 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 GALILEO GOLD?

GALILEO GOLD is a medical device that received FDA 510(k) clearance on 2004-10-27. The listed applicant is Hamilton Medical, Inc.. The 510(k) number is K040574.

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

GALILEO GOLD received FDA 510(k) clearance on 2004-10-27, under 510(k) number K040574.

Who is the listed applicant for GALILEO GOLD?

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

What is the FDA product code for GALILEO GOLD?

The FDA product code for GALILEO GOLD is CBK.

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Other records listing Hamilton Medical, 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.

K001686GALILEO VENTILATORK982910HAMILTON MEDICAL GALILEOVENTILATORK990293ALADDIN II MONITORING OXYGEN/AIR MONITORK960359ALADDIN MONITORING OXYGEN/AIR MIXERK945740INFANT FLOW SYSTEMK901448VEOLAR VENTILATOR

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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.

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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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