K200957 is an FDA 510(k) clearance for the Brainsway Deep TMS 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 August 21, 2020, 134 days after receiving the submission on April 9, 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 | K200957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2020 |
| Decision Date | August 21, 2020 |
| Days to Decision | 134 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. |