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FDA 510(k), K190285, L300 Go System
FDA 510(k), K190285, L300 Go System
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$149.00 USD
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$149.00 USD
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510(K) Number: K190285
Device Name: L300 Go System
Manufacturer: Bioness Inc.
Device Classification Name: Stimulator, Neuromuscular, External Functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 02/11/2019
Decision Date: 03/14/2019
Regulation Medical Specialty: Neurology
Device Name: L300 Go System
Manufacturer: Bioness Inc.
Device Classification Name: Stimulator, Neuromuscular, External Functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 02/11/2019
Decision Date: 03/14/2019
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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