The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Tomey Pe-300 Portable Erg.
| Device ID | K921815 |
| 510k Number | K921815 |
| Device Name: | TOMEY PE-300 PORTABLE ERG |
| Classification | Preamplifier, Ac-powered, Ophthalmic |
| Applicant | TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Contact | Lori A Truitt |
| Correspondent | Lori A Truitt TOMEY CORPORATION USA 325 VASSAR ST. 2ND FLOOR Cambridge, MA 02139 |
| Product Code | HLT |
| CFR Regulation Number | 886.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-15 |
| Decision Date | 1992-07-15 |