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FDA 510(k), K133868, ASTRAL VENTILATOR
FDA 510(k), K133868, ASTRAL VENTILATOR
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510(K) Number: K133868
Device Name: ASTRAL VENTILATOR
Manufacturer: JIM CASSI
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: 12/20/2013
Date Received: 06/04/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ASTRAL VENTILATOR
Manufacturer: JIM CASSI
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: 12/20/2013
Date Received: 06/04/2014
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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