The following data is part of a De Novo classification by Brainways Ltd. with the FDA for Brainsway Deep Transcranial Magnetic Stimulation (dtms) System.
DeNovo ID | DEN170078 |
Device Name: | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System |
Classification | Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder |
Applicant | Brainways Ltd. bynet Bldg. P.o.b. 45169 19 Hartum Str. Har Hotzvim, IL 9777518 |
Contact | Ahava Stein |
Product Code | QCI |
CFR Regulation Number | 882.5802 [🔎] |
Decision | Granted (DENG) |
510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
Review Advisory Board | Neurology |
Classification Advisory | Neurology |
Type | Direct |
Date Received | 2017-09-29 |
Decision Date | 2018-08-17 |
FDA Review | Decision Summary |
Reclassification Order: | Reclassification Order |