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FDA 510(k), K192606, SAC2 - Electrode Cream
FDA 510(k), K192606, SAC2 - Electrode Cream
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510(K) Number: K192606
Device Name: SAC2 - Electrode Cream
Manufacturer: Spes Medica S.r.l.
Device Classification Name: media, electroconductive
Regulation Number: 882.1275
Classification Product Code: GYB
Date Received: 09/20/2019
Decision Date: 01/17/2020
Regulation Medical Specialty: Neurology
Device Name: SAC2 - Electrode Cream
Manufacturer: Spes Medica S.r.l.
Device Classification Name: media, electroconductive
Regulation Number: 882.1275
Classification Product Code: GYB
Date Received: 09/20/2019
Decision Date: 01/17/2020
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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