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FDA 510(k)

HAMILTON MEDICAL GALILEOVENTILATOR

K-Number: K982910 · 1999-09-14

ApplicantHamilton Medical, Inc.
Decision Date1999-09-14
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HAMILTON MEDICAL GALILEOVENTILATOR 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 1999-09-14 under 510(k) number K982910. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the HAMILTON MEDICAL GALILEOVENTILATOR?

HAMILTON MEDICAL GALILEOVENTILATOR is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Hamilton Medical, Inc.. The 510(k) number is K982910.

When did HAMILTON MEDICAL GALILEOVENTILATOR receive FDA 510(k) clearance?

HAMILTON MEDICAL GALILEOVENTILATOR received FDA 510(k) clearance on 1999-09-14, under 510(k) number K982910.

Who is the listed applicant for HAMILTON MEDICAL GALILEOVENTILATOR?

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 HAMILTON MEDICAL GALILEOVENTILATOR?

The FDA product code for HAMILTON MEDICAL GALILEOVENTILATOR 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.

K040574GALILEO GOLDK001686GALILEO VENTILATORK990293ALADDIN 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.

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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