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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: KXA
Date Received: 12/20/2013
Decision Date: 06/04/2014
Decision: 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: KXA
Date Received: 12/20/2013
Decision Date: 06/04/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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