The following data is part of a premarket notification filed by Mag & More Gmbh with the FDA for Apollo Tms Therapy System.
| Device ID | K180313 |
| 510k Number | K180313 |
| Device Name: | Apollo TMS Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Mag & More GmbH Machtlfinger Strasse L3 Munich, DE 81379 |
| Contact | Kerstin Haringer |
| Correspondent | Kerstin Haringer Mag & More GmbH Machtlfinger Strasse L3 Munich, DE 81379 |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-05 |
| Decision Date | 2018-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260526050019 | K180313 | 000 |