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FDA 510(k)

AVEA

K-Number: K013642 · 2002-05-22

ApplicantBird Products Corp.
Decision Date2002-05-22
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AVEA is the device name listed in this FDA 510(k) record. The listed applicant is Bird Products Corp.. It received FDA 510(k) clearance on 2002-05-22 under 510(k) number K013642. 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?

AVEA is a medical device that received FDA 510(k) clearance on 2002-05-22. The listed applicant is Bird Products Corp.. The 510(k) number is K013642.

When did AVEA receive FDA 510(k) clearance?

AVEA received FDA 510(k) clearance on 2002-05-22, under 510(k) number K013642.

Who is the listed applicant for AVEA?

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

What is the FDA product code for AVEA?

The FDA product code for AVEA is CBK.

Other records listing Bird Products Corp. 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.

K032451BIRD TBIRD VELA VENTILATORK022674BIRD AVEA VENTILATORK020730ORION NASAL CPAP SYSTEMK020746BIRD TBIRD VELA VENTILATORK003770BIRD TBIRD LEGACY VENTILATORK990856HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682

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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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