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FDA 510(k), K152911, EarlySense Insight Sytem
FDA 510(k), K152911, EarlySense Insight Sytem
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510(K) Number: K152911
Device Name: EarlySense Insight Sytem
Manufacturer: EarlySense Ltd.
Device Classification Name: monitor, breathing frequency
Regulation Number: 868.2375
Classification Product Code: BZQ
Date Received: 10/02/2015
Decision Date: 05/06/2016
Regulation Medical Specialty: Anesthesiology
Device Name: EarlySense Insight Sytem
Manufacturer: EarlySense Ltd.
Device Classification Name: monitor, breathing frequency
Regulation Number: 868.2375
Classification Product Code: BZQ
Date Received: 10/02/2015
Decision Date: 05/06/2016
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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