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FDA 510(k)

MODIFICATION TO HAMILTON-G5

K-Number: K081521 · 2008-09-25

ApplicantHamilton Medical AG
Decision Date2008-09-25
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HAMILTON-G5 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 2008-09-25 under 510(k) number K081521. 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 HAMILTON-G5?

MODIFICATION TO HAMILTON-G5 is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Hamilton Medical AG. The 510(k) number is K081521.

When did MODIFICATION TO HAMILTON-G5 receive FDA 510(k) clearance?

MODIFICATION TO HAMILTON-G5 received FDA 510(k) clearance on 2008-09-25, under 510(k) number K081521.

Who is the listed applicant for MODIFICATION TO HAMILTON-G5?

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 HAMILTON-G5?

The FDA product code for MODIFICATION TO HAMILTON-G5 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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