K203616 is an FDA 510(k) clearance for the Brainsway Deep (DTMS) System. This device is classified as a Transcranial Magnetic Stimulation System For Smoking Cessation (Class II - Special Controls, product code QMD).
Submitted by Brainsway , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on April 16, 2021, 127 days after receiving the submission on December 10, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5802. Intended For Use As A Transcranial Magnetic Stimulation System For Neurological And Psychiatric Disorders And Conditions..
| 510(k) Number | K203616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 2020 |
| Decision Date | April 16, 2021 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QMD - Transcranial Magnetic Stimulation System For Smoking Cessation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5802 |
| Definition | Intended For Use As A Transcranial Magnetic Stimulation System For Neurological And Psychiatric Disorders And Conditions. |