The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Tomey Pe-400 Portable Erg & Vep With Optional Ps-4.
| Device ID | K932571 |
| 510k Number | K932571 |
| Device Name: | TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 |
| Classification | Stimulator, Photic, Evoked Response |
| Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Contact | Lori Truitt |
| Correspondent | Lori Truitt TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Product Code | GWE |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-27 |
| Decision Date | 1995-08-31 |