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FDA 510(k), K050918, KOO AMERICAS VALVE PEEP, MODEL KM-809
FDA 510(k), K050918, KOO AMERICAS VALVE PEEP, MODEL KM-809
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510(K) Number: K050918
Device Name: KOO AMERICAS VALVE PEEP, MODEL KM-809
Manufacturer: KOO AMERICAS, INC.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 04/12/2005
Decision Date: 06/06/2005
Regulation Medical Specialty: Anesthesiology
Device Name: KOO AMERICAS VALVE PEEP, MODEL KM-809
Manufacturer: KOO AMERICAS, INC.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 04/12/2005
Decision Date: 06/06/2005
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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