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FDA 510(k)

VEOLAR VENTILATOR

K-Number: K861432 · 1986-05-06

ApplicantHamilton Medical, Inc.
Decision Date1986-05-06
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VEOLAR VENTILATOR 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 1986-05-06 under 510(k) number K861432. 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 VEOLAR VENTILATOR?

VEOLAR VENTILATOR is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Hamilton Medical, Inc.. The 510(k) number is K861432.

When did VEOLAR VENTILATOR receive FDA 510(k) clearance?

VEOLAR VENTILATOR received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861432.

Who is the listed applicant for VEOLAR VENTILATOR?

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 VEOLAR VENTILATOR?

The FDA product code for VEOLAR VENTILATOR 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 VENTILATORK982910HAMILTON MEDICAL GALILEOVENTILATORK990293ALADDIN II MONITORING OXYGEN/AIR MONITORK960359ALADDIN MONITORING OXYGEN/AIR MIXERK945740INFANT FLOW SYSTEM

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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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