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)

VM-2000

K-Number: K240807 · 2024-08-13

ApplicantVentis Medical, Inc.
Decision Date2024-08-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VM-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Ventis Medical, Inc.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K240807. 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 VM-2000?

VM-2000 is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Ventis Medical, Inc.. The 510(k) number is K240807.

When did VM-2000 receive FDA 510(k) clearance?

VM-2000 received FDA 510(k) clearance on 2024-08-13, under 510(k) number K240807.

Who is the listed applicant for VM-2000?

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

What is the FDA product code for VM-2000?

The FDA product code for VM-2000 is CBK.

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.

↑