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FDA 510(k)

IVENT 201

K-Number: K053270 · 2006-01-27

ApplicantVersamed Medical Systems, Inc.
Decision Date2006-01-27
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IVENT 201 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 2006-01-27 under 510(k) number K053270. 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 IVENT 201?

IVENT 201 is a medical device that received FDA 510(k) clearance on 2006-01-27. The listed applicant is Versamed Medical Systems, Inc.. The 510(k) number is K053270.

When did IVENT 201 receive FDA 510(k) clearance?

IVENT 201 received FDA 510(k) clearance on 2006-01-27, under 510(k) number K053270.

Who is the listed applicant for IVENT 201?

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 IVENT 201?

The FDA product code for IVENT 201 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.

K081845IVENT101K073694IVENT 2001 MRI CONDITIONALK061627MODIFICATION TO I VENT 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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