1
/
of
0
FDA 510(k), K230173, Servo-air Lite Ventilator System
FDA 510(k), K230173, Servo-air Lite Ventilator System
Regular price
$89.00 USD
Regular price
Sale price
$89.00 USD
Unit price
/
per
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: KXA
Date Received: 01/20/2023
Decision Date: 07/06/2023
Decision: 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: KXA
Date Received: 01/20/2023
Decision Date: 07/06/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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.
View full details