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FDA 510(k)

AVEA VENTILATOR

K-Number: K103211 · 2011-05-12

ApplicantCare Fusion
Decision Date2011-05-12
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AVEA VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2011-05-12 under 510(k) number K103211. 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 AVEA VENTILATOR?

AVEA VENTILATOR is a medical device that received FDA 510(k) clearance on 2011-05-12. The listed applicant is Care Fusion. The 510(k) number is K103211.

When did AVEA VENTILATOR receive FDA 510(k) clearance?

AVEA VENTILATOR received FDA 510(k) clearance on 2011-05-12, under 510(k) number K103211.

Who is the listed applicant for AVEA VENTILATOR?

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

What is the FDA product code for AVEA VENTILATOR?

The FDA product code for AVEA VENTILATOR is CBK.

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Other records listing Care Fusion as applicant

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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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