The following data is part of a premarket notification filed by Tms International Bv with the FDA for Porti 7 Physiological Amplifier.
| Device ID | K063599 |
| 510k Number | K063599 |
| Device Name: | PORTI 7 PHYSIOLOGICAL AMPLIFIER |
| Classification | Amplifier, Physiological Signal |
| Applicant | TMS INTERNATIONAL BV 7744 SWAPS TRAIL Evergreen, CO 80439 |
| Contact | David W Wagner |
| Correspondent | David W Wagner TMS INTERNATIONAL BV 7744 SWAPS TRAIL Evergreen, CO 80439 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-04 |
| Decision Date | 2007-03-22 |