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FDA 510(k), K061090, GALILEO GOLD ASV
FDA 510(k), K061090, GALILEO GOLD ASV
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510(K) Number: K061090
Device Name: GALILEO GOLD ASV
Manufacturer: JOERG SCHNEIDER
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 04/18/2006
Decision Date: 07/17/2006
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: GALILEO GOLD ASV
Manufacturer: JOERG SCHNEIDER
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 04/18/2006
Decision Date: 07/17/2006
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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