FDA.report

510(k) K223120

Device
Ventoux VC2; Ventoux VC3
Applicant
Flight Medical Innovations , Ltd.
510(k) number
K223120
Product code
CBK
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-02
Date received
2022-10-03
Regulation
868.5895
Classification name
Ventilator, Continuous, Facility Use
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ken Raichman
Address
7 Hatnufa St. Petach Tikva IL 4951025 4951025

FDA Registration Numbers

Source Documents

510(k) summary PDF

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