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FDA 510(k)

IVENT101

K-Number: K112754 · 2012-06-15

ApplicantVersamed Medical Systems , Ltd.
Decision Date2012-06-15
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IVENT101 is the device name listed in this FDA 510(k) record. The listed applicant is Versamed Medical Systems , Ltd.. It received FDA 510(k) clearance on 2012-06-15 under 510(k) number K112754. 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 IVENT101?

IVENT101 is a medical device that received FDA 510(k) clearance on 2012-06-15. The listed applicant is Versamed Medical Systems , Ltd.. The 510(k) number is K112754.

When did IVENT101 receive FDA 510(k) clearance?

IVENT101 received FDA 510(k) clearance on 2012-06-15, under 510(k) number K112754.

Who is the listed applicant for IVENT101?

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

What is the FDA product code for IVENT101?

The FDA product code for IVENT101 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 Versamed Medical Systems , 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.

K092135MODIFICATION TO IVENT 101

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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