FDA 510(k), K191080, Ambu aScope 4 RhinoLaryngo Slim
FDA 510(k), K191080, Ambu aScope 4 RhinoLaryngo Slim
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510(K) Number: K191080
Device Name: Ambu aScope 4 RhinoLaryngo Slim
Manufacturer: Ambu A/S
Device Classification Name: Nasopharyngoscope (Flexible Or Rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 04/24/2019
Decision Date: 05/22/2019
Regulation Medical Specialty: Ear Nose & Throat
Device Name: Ambu aScope 4 RhinoLaryngo Slim
Manufacturer: Ambu A/S
Device Classification Name: Nasopharyngoscope (Flexible Or Rigid)
Regulation Number: 874.4760
Classification Product Code: EOB
Date Received: 04/24/2019
Decision Date: 05/22/2019
Regulation Medical Specialty: Ear Nose & Throat
- 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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