The following data is part of a premarket notification filed by Advantage Medical Division Of Cme Telemetrix with the FDA for Advantage Emg System, Model #a100.
| Device ID | K974010 |
| 510k Number | K974010 |
| Device Name: | ADVANTAGE EMG SYSTEM, MODEL #A100 |
| Classification | Electromyograph, Diagnostic |
| Applicant | ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX 100 COLLIP CIRCLE, #100 London, CA N6g 4x8 |
| Contact | Robert Snow |
| Correspondent | Robert Snow ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX 100 COLLIP CIRCLE, #100 London, CA N6g 4x8 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-21 |
| Decision Date | 1998-01-16 |
| Summary: | summary |