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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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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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