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FDA 510(k), K123701, HEARLAB ACA
FDA 510(k), K123701, HEARLAB ACA
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510(K) Number: K123701
Device Name: HEARLAB ACA
Manufacturer: FRYE ELECTRONICS, INC.
Device Classification Name: Stimulator, Auditory, Evoked Response
Regulation Number: 882.1900
Classification Product Code: GWJ
Date Received: 12/03/2012
Decision Date: 04/05/2013
Regulation Medical Specialty: Neurology
Device Name: HEARLAB ACA
Manufacturer: FRYE ELECTRONICS, INC.
Device Classification Name: Stimulator, Auditory, Evoked Response
Regulation Number: 882.1900
Classification Product Code: GWJ
Date Received: 12/03/2012
Decision Date: 04/05/2013
Regulation Medical Specialty: Neurology
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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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