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FDA 510(k), K080219, MODIFICATION TO:NESS L300
FDA 510(k), K080219, MODIFICATION TO:NESS L300
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510(K) Number: K080219
Device Name: MODIFICATION TO:NESS L300
Manufacturer: NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Device Classification Name: stimulator, neuromuscular, external functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 01/29/2008
Decision Date: 02/28/2008
Regulation Medical Specialty: Neurology
Device Name: MODIFICATION TO:NESS L300
Manufacturer: NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
Device Classification Name: stimulator, neuromuscular, external functional
Regulation Number: 882.5810
Classification Product Code: GZI
Date Received: 01/29/2008
Decision Date: 02/28/2008
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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