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FDA 510(k), K181405, Hailie Sensor
FDA 510(k), K181405, Hailie Sensor
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510(K) Number: K181405
Device Name: Hailie Sensor
Manufacturer: Adherium (NZ) Ltd
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 05/29/2018
Decision Date: 12/10/2018
Regulation Medical Specialty: Anesthesiology
Device Name: Hailie Sensor
Manufacturer: Adherium (NZ) Ltd
Device Classification Name: nebulizer (direct patient interface)
Regulation Number: 868.5630
Classification Product Code: CAF
Date Received: 05/29/2018
Decision Date: 12/10/2018
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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