The following data is part of a premarket notification filed by Laborie Medical Technologies, Inc. with the FDA for Evox Electro Diagnostic Device.
| Device ID | K082614 |
| 510k Number | K082614 |
| Device Name: | EVOX ELECTRO DIAGNOSTIC DEVICE |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | LABORIE MEDICAL TECHNOLOGIES, INC. 400 AVENUE D SUITE 10 Williston, VT 05495 |
| Contact | Barbara Mornet |
| Correspondent | Barbara Mornet LABORIE MEDICAL TECHNOLOGIES, INC. 400 AVENUE D SUITE 10 Williston, VT 05495 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-09 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00627825005296 | K082614 | 000 |
| 00627825005289 | K082614 | 000 |
| 00627825004275 | K082614 | 000 |