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FDA 510(k), K173681, reSET-O
FDA 510(k), K173681, reSET-O
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$149.00 USD
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510(K) Number: K173681
Device Name: reSET-O
Manufacturer: Yuri Maricich
Device Classification Name: Computerized Behavioral Therapy Device For Substance Use Disorders
Regulation Number: PWE
Classification Product Code: 12/01/2017
Date Received: 12/10/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: reSET-O
Manufacturer: Yuri Maricich
Device Classification Name: Computerized Behavioral Therapy Device For Substance Use Disorders
Regulation Number: PWE
Classification Product Code: 12/01/2017
Date Received: 12/10/2018
Decision Date: Substantially Equivalent (SESE)
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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