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FDA 510(k)

INSPIRATION VENTILATOR SYSTEM 5I/7I

K-Number: K130178 · 2013-10-29

ApplicanteVent Medical, Ltd.
Decision Date2013-10-29
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INSPIRATION VENTILATOR SYSTEM 5I/7I is the device name listed in this FDA 510(k) record. The listed applicant is eVent Medical, Ltd.. It received FDA 510(k) clearance on 2013-10-29 under 510(k) number K130178. 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 INSPIRATION VENTILATOR SYSTEM 5I/7I?

INSPIRATION VENTILATOR SYSTEM 5I/7I is a medical device that received FDA 510(k) clearance on 2013-10-29. The listed applicant is eVent Medical, Ltd.. The 510(k) number is K130178.

When did INSPIRATION VENTILATOR SYSTEM 5I/7I receive FDA 510(k) clearance?

INSPIRATION VENTILATOR SYSTEM 5I/7I received FDA 510(k) clearance on 2013-10-29, under 510(k) number K130178.

Who is the listed applicant for INSPIRATION VENTILATOR SYSTEM 5I/7I?

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

What is the FDA product code for INSPIRATION VENTILATOR SYSTEM 5I/7I?

The FDA product code for INSPIRATION VENTILATOR SYSTEM 5I/7I 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 eVent Medical, Ltd. 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.

K051550INSPIRATION VENTILATOR SYSTEMK040220MEDICAL AIR COMPRESSORK030341MODIFICATION TO INSPIRATION VENTILATOR SYSTEMK021112INSPIRATION VENTILATOR SYSTEM

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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