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FDA 510(k), K131285, SONOSENTRY
FDA 510(k), K131285, SONOSENTRY
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510(K) Number: K131285
Device Name: SONOSENTRY
Manufacturer: ISONEA LTD
Device Classification Name: abnormal breath sound device
Regulation Number: 868.1900
Classification Product Code: PHZ
Date Received: 05/06/2013
Decision Date: 08/19/2014
Regulation Medical Specialty: Anesthesiology
Device Name: SONOSENTRY
Manufacturer: ISONEA LTD
Device Classification Name: abnormal breath sound device
Regulation Number: 868.1900
Classification Product Code: PHZ
Date Received: 05/06/2013
Decision Date: 08/19/2014
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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