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FDA 510(k), K173760, Monarch Endoscopy Platform (Monarch Platform)
FDA 510(k), K173760, Monarch Endoscopy Platform (Monarch Platform)
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510(K) Number: K173760
Device Name: Monarch Endoscopy Platform (Monarch Platform)
Manufacturer: Auris Surgical Robotics, Inc.
Device Classification Name: bronchoscope (flexible or rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 12/11/2017
Decision Date: 03/22/2018
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Monarch Endoscopy Platform (Monarch Platform)
Manufacturer: Auris Surgical Robotics, Inc.
Device Classification Name: bronchoscope (flexible or rigid)
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 12/11/2017
Decision Date: 03/22/2018
Regulation Medical Specialty: Ear Nose & Throat
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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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