The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Rapid2 Therapy System.
| Device ID | K162935 |
| 510k Number | K162935 |
| Device Name: | Rapid2 Therapy System |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | MAGSTIM COMPANY LTD. SPRING GARDENS Whitland, GB Sa34 0hr |
| Contact | Kevyn Beard |
| Correspondent | Kevyn Beard MAGSTIM COMPANY LTD. SPRING GARDENS Whitland, GB Sa34 0hr |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-20 |
| Decision Date | 2017-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229532169 | K162935 | 000 |