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FDA 510(k)

MODIFICATION TO: PNEUTON VENTILATOR

K-Number: K043085 · 2004-12-20

ApplicantAiron Corporation
Decision Date2004-12-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: PNEUTON VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Airon Corporation. It received FDA 510(k) clearance on 2004-12-20 under 510(k) number K043085. 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: PNEUTON VENTILATOR?

MODIFICATION TO: PNEUTON VENTILATOR is a medical device that received FDA 510(k) clearance on 2004-12-20. The listed applicant is Airon Corporation. The 510(k) number is K043085.

When did MODIFICATION TO: PNEUTON VENTILATOR receive FDA 510(k) clearance?

MODIFICATION TO: PNEUTON VENTILATOR received FDA 510(k) clearance on 2004-12-20, under 510(k) number K043085.

Who is the listed applicant for MODIFICATION TO: PNEUTON VENTILATOR?

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

What is the FDA product code for MODIFICATION TO: PNEUTON VENTILATOR?

The FDA product code for MODIFICATION TO: PNEUTON VENTILATOR is CBK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Airon Corporation 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.

K121379PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORYK080692MACS CPAP SYSTEMK024344PNEUTON VENTILATOR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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