K232688 is an FDA 510(k) clearance for the NQ TMS for MDD (NQv1-MU-01). This device is classified as a Transcranial Magnetic Stimulator (Class II - Special Controls, product code OBP).
Submitted by Neuroqore, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 29, 2023, 119 days after receiving the submission on September 1, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5805. A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder..
| 510(k) Number | K232688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2023 |
| Decision Date | December 29, 2023 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OBP - Transcranial Magnetic Stimulator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5805 |
| Definition | A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder. |