The following data is part of a premarket notification filed by Amplaid Usa, Inc. with the FDA for Amplaid Mk15 (evoked Potential System).
| Device ID | K861014 |
| 510k Number | K861014 |
| Device Name: | AMPLAID MK15 (EVOKED POTENTIAL SYSTEM) |
| Classification | Amplifier, Physiological Signal |
| Applicant | AMPLAID USA, INC. 1225 CARNEGIE, UNIT 104 Rolling Meadows, IL 60008 |
| Contact | Gian P Mazzoni |
| Correspondent | Gian P Mazzoni AMPLAID USA, INC. 1225 CARNEGIE, UNIT 104 Rolling Meadows, IL 60008 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-18 |
| Decision Date | 1986-08-20 |