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FDA 510(k), K191031, NightOwl
FDA 510(k), K191031, NightOwl
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$149.00 USD
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510(K) Number: K191031
Device Name: NightOwl
Manufacturer: Ectosense nv
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 04/18/2019
Decision Date: 03/06/2020
Regulation Medical Specialty: Anesthesiology
Device Name: NightOwl
Manufacturer: Ectosense nv
Device Classification Name: Ventilatory Effort Recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 04/18/2019
Decision Date: 03/06/2020
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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