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)

VELA VENTILATOR

K-Number: K093094 · 2010-05-11

ApplicantCardinal Health 207, Inc.
Decision Date2010-05-11
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VELA VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 207, Inc.. It received FDA 510(k) clearance on 2010-05-11 under 510(k) number K093094. 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 VELA VENTILATOR?

VELA VENTILATOR is a medical device that received FDA 510(k) clearance on 2010-05-11. The listed applicant is Cardinal Health 207, Inc.. The 510(k) number is K093094.

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

VELA VENTILATOR received FDA 510(k) clearance on 2010-05-11, under 510(k) number K093094.

Who is the listed applicant for VELA VENTILATOR?

The FDA 510(k) record lists Cardinal Health 207, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VELA VENTILATOR?

The FDA product code for 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 Cardinal Health 207, 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.

K092484HELIOX LOW FLOW SENTRY BLENDERK093124PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03K081670THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASKK081837AVEA 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.

↑