K240807

VM-2000

510(k) number
K240807
Device name
VM-2000
Applicant
Ventis Medical, Inc. NJ · US
Product code
CBK — Ventilator, Continuous, Facility Use
Decision date
2024-08-13
Date received
2024-03-25
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain

Also available from FDA: K240807.pdf

Official FDA record: K240807
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.