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FDA 510(k), K083050, EVITE XL
FDA 510(k), K083050, EVITE XL
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510(K) Number: K083050
Device Name: EVITE XL
Manufacturer: JOYCE KILROY
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 10/14/2008
Decision Date: 12/29/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: EVITE XL
Manufacturer: JOYCE KILROY
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 10/14/2008
Decision Date: 12/29/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- 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.
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