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FDA 510(k), K173974, DROWZLE
FDA 510(k), K173974, DROWZLE
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510(K) Number: K173974
Device Name: DROWZLE
Manufacturer: Resonea, Inc.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 12/29/2017
Decision Date: 07/14/2019
Regulation Medical Specialty: Anesthesiology
Device Name: DROWZLE
Manufacturer: Resonea, Inc.
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 12/29/2017
Decision Date: 07/14/2019
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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