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FDA 510(k), K103316, FLOWREST
FDA 510(k), K103316, FLOWREST
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510(K) Number: K103316
Device Name: FLOWREST
Manufacturer: VAPOTHERM, INC.
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 11/10/2010
Decision Date: 02/08/2011
Regulation Medical Specialty: Anesthesiology
Device Name: FLOWREST
Manufacturer: VAPOTHERM, INC.
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 11/10/2010
Decision Date: 02/08/2011
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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