The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel Emg.
| Device ID | K941144 |
| 510k Number | K941144 |
| Device Name: | EXCEL EMG |
| Classification | Electromyograph, Diagnostic |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | John Mumford |
| Correspondent | John Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-10 |
| Decision Date | 1995-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830016094 | K941144 | 000 |
| 00382830000567 | K941144 | 000 |
| 00382830001250 | K941144 | 000 |
| 00382830002264 | K941144 | 000 |
| 00382830002325 | K941144 | 000 |
| 00382830002370 | K941144 | 000 |
| 00382830002608 | K941144 | 000 |
| 00382830002622 | K941144 | 000 |
| 00382830002943 | K941144 | 000 |
| 00382830000000 | K941144 | 000 |