Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIRD TBIRD VELA VENTILATOR

K-Number: K020746 · 2002-04-22

ApplicantBird Products Corp.
Decision Date2002-04-22
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIRD TBIRD VELA 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 2002-04-22 under 510(k) number K020746. 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 BIRD TBIRD VELA VENTILATOR?

BIRD TBIRD VELA VENTILATOR is a medical device that received FDA 510(k) clearance on 2002-04-22. The listed applicant is Bird Products Corp.. The 510(k) number is K020746.

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

BIRD TBIRD VELA VENTILATOR received FDA 510(k) clearance on 2002-04-22, under 510(k) number K020746.

Who is the listed applicant for BIRD TBIRD VELA 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 VELA VENTILATOR?

The FDA product code for BIRD TBIRD VELA 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK013642AVEAK003770BIRD TBIRD LEGACY VENTILATORK990856HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682

View all 35 devices →

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.

↑