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FDA 510(k), K230173, Servo-air Lite Ventilator System
FDA 510(k), K230173, Servo-air Lite Ventilator System
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510(K) Number: K230173
Device Name: Servo-air Lite Ventilator System
Manufacturer: David Ardanius
Device Classification Name: Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Regulation Number: MNT
Classification Product Code: 01/20/2023
Date Received: 07/06/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Servo-air Lite Ventilator System
Manufacturer: David Ardanius
Device Classification Name: Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Regulation Number: MNT
Classification Product Code: 01/20/2023
Date Received: 07/06/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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