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FDA 510(k)

IVENT101

K-Number: K081845 · 2009-03-16

ApplicantVersamed Medical Systems, Inc.
Decision Date2009-03-16
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, Inc.. It received FDA 510(k) clearance on 2009-03-16 under 510(k) number K081845. 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 2009-03-16. The listed applicant is Versamed Medical Systems, Inc.. The 510(k) number is K081845.

When did IVENT101 receive FDA 510(k) clearance?

IVENT101 received FDA 510(k) clearance on 2009-03-16, under 510(k) number K081845.

Who is the listed applicant for IVENT101?

The FDA 510(k) record lists Versamed Medical Systems, Inc. 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.

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Other records listing Versamed Medical Systems, 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.

K073694IVENT 2001 MRI CONDITIONALK061627MODIFICATION TO I VENT 201K053270IVENT 201K052554MODIFICATION TO: IVENT 201 PORTABLE VENTILATORK042468IVENT 201 PORTABLE 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

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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