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FDA 510(k), K160309, Neurosoft TMS
FDA 510(k), K160309, Neurosoft TMS
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510(K) Number: K160309
Device Name: Neurosoft TMS
Manufacturer: Joe F Jabre
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: OBP
Classification Product Code: KXA
Date Received: 02/04/2016
Decision Date: 12/22/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Neurosoft TMS
Manufacturer: Joe F Jabre
Device Classification Name: Transcranial Magnetic Stimulator
Regulation Number: OBP
Classification Product Code: KXA
Date Received: 02/04/2016
Decision Date: 12/22/2016
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
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