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FDA 510(k), K152319, Auris Robotic Endoscopy System (ARES)
FDA 510(k), K152319, Auris Robotic Endoscopy System (ARES)
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510(K) Number: K152319
Device Name: Auris Robotic Endoscopy System (ARES)
Manufacturer: MICHAEL A. DANIEL
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: 08/17/2015
Date Received: 05/26/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Auris Robotic Endoscopy System (ARES)
Manufacturer: MICHAEL A. DANIEL
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: 08/17/2015
Date Received: 05/26/2016
Decision Date: Substantially Equivalent (SESE)
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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