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FDA 510(k), K222983, NeuroBlate Fusion-S Software V3.17
FDA 510(k), K222983, NeuroBlate Fusion-S Software V3.17
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510(K) Number: K222983
Device Name: NeuroBlate Fusion-S Software V3.17
Manufacturer: David H Mueller
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 09/28/2022
Decision Date: 03/15/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: NeuroBlate Fusion-S Software V3.17
Manufacturer: David H Mueller
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: KXA
Date Received: 09/28/2022
Decision Date: 03/15/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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