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FDA 510(k), K131285, SONOSENTRY
FDA 510(k), K131285, SONOSENTRY
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$149.00 USD
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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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- 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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