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FDA 510(k)

BIRD TBIRD LEGACY VENTILATOR

K-Number: K003770 · 2000-12-15

ApplicantBird Products Corp.
Decision Date2000-12-15
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

BIRD TBIRD LEGACY VENTILATOR 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 2000-12-15 under 510(k) number K003770. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the BIRD TBIRD LEGACY VENTILATOR?

BIRD TBIRD LEGACY VENTILATOR is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Bird Products Corp.. The 510(k) number is K003770.

When did BIRD TBIRD LEGACY VENTILATOR receive FDA 510(k) clearance?

BIRD TBIRD LEGACY VENTILATOR received FDA 510(k) clearance on 2000-12-15, under 510(k) number K003770.

Who is the listed applicant for BIRD TBIRD LEGACY VENTILATOR?

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 BIRD TBIRD LEGACY VENTILATOR?

The FDA product code for BIRD TBIRD LEGACY VENTILATOR 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 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 VENTILATORK013642AVEAK020730ORION NASAL CPAP SYSTEMK020746BIRD TBIRD VELA 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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