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FDA 510(k), K172460, ADHEAR System
FDA 510(k), K172460, ADHEAR System
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510(K) Number: K172460
Device Name: ADHEAR System
Manufacturer: MED-EL Elektromedizinische Geraete GmbH
Device Classification Name: hearing aid, bone conduction
Regulation Number: 874.3302
Classification Product Code: LXB
Date Received: 08/14/2017
Decision Date: 04/27/2018
Regulation Medical Specialty: Ear Nose & Throat
Device Name: ADHEAR System
Manufacturer: MED-EL Elektromedizinische Geraete GmbH
Device Classification Name: hearing aid, bone conduction
Regulation Number: 874.3302
Classification Product Code: LXB
Date Received: 08/14/2017
Decision Date: 04/27/2018
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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