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FDA 510(k), K110486, ACCUSOM
FDA 510(k), K110486, ACCUSOM
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510(K) Number: K110486
Device Name: ACCUSOM
Manufacturer: NOVASOM, INC.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 02/22/2011
Decision Date: 08/12/2011
Regulation Medical Specialty: Anesthesiology
Device Name: ACCUSOM
Manufacturer: NOVASOM, INC.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 02/22/2011
Decision Date: 08/12/2011
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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