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FDA 510(k), K120931, CRITICAL CARE VENTILATOR
FDA 510(k), K120931, CRITICAL CARE VENTILATOR
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510(K) Number: K120931
Device Name: CRITICAL CARE VENTILATOR
Manufacturer: DAVID JAMISON
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 03/27/2012
Decision Date: 06/06/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: CRITICAL CARE VENTILATOR
Manufacturer: DAVID JAMISON
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 03/27/2012
Decision Date: 06/06/2013
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
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