The following data is part of a premarket notification filed by Eneura Inc with the FDA for Stms Mini.
| Device ID | K161663 |
| 510k Number | K161663 |
| Device Name: | STMS Mini |
| Classification | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Applicant | ENEURA INC 715 NORTH PASTORIA AVENUE Sunnyvale, CA 94085 |
| Contact | Cynthia Merrell |
| Correspondent | Larry W. Getlin LARRY W. GETLIN 2690 PHEASANT ROAD Orono, MN 55331 |
| Product Code | OKP |
| CFR Regulation Number | 882.5808 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-16 |
| Decision Date | 2016-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816140020125 | K161663 | 000 |
| 00816140020118 | K161663 | 000 |
| 00816140020095 | K161663 | 000 |
| 00816140020088 | K161663 | 000 |
| 00816140020071 | K161663 | 000 |
| 00816140020132 | K161663 | 000 |