The following data is part of a premarket notification filed by Meps, Llc. with the FDA for Digitimer D185 Multipulse Cortical Stimulator.
| Device ID | K020400 |
| 510k Number | K020400 |
| Device Name: | DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | MEPS, LLC. ONE EAST BROWARD BLVD #700 Fort Lauderdale, FL 33301 |
| Contact | Harry Benedict |
| Correspondent | Harry Benedict MEPS, LLC. ONE EAST BROWARD BLVD #700 Fort Lauderdale, FL 33301 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-06 |
| Decision Date | 2002-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060490360041 | K020400 | 000 |