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FDA 510(k), K151979, STARband, STARlight
FDA 510(k), K151979, STARband, STARlight
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510(K) Number: K151979
Device Name: STARband, STARlight
Manufacturer: DAVID C. KERR
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: 07/17/2015
Date Received: 09/18/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: STARband, STARlight
Manufacturer: DAVID C. KERR
Device Classification Name: Orthosis, Cranial, Laser Scan
Regulation Number: OAN
Classification Product Code: 07/17/2015
Date Received: 09/18/2015
Decision Date: Substantially Equivalent (SESE)
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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