The following data is part of a premarket notification filed by Excel Tech. Ltd. with the FDA for Excel Av Stim 1000.
| Device ID | K972157 |
| 510k Number | K972157 |
| Device Name: | EXCEL AV STIM 1000 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Contact | John R Mumford |
| Correspondent | John R Mumford EXCEL TECH. LTD. 2892 PORTLAND DR. Oakville,ontario, CA L6h 5w8 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1998-01-30 |