The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Multi-stim, Model Ms-100.
| Device ID | K001897 |
| 510k Number | K001897 |
| Device Name: | MULTI-STIM, MODEL MS-100 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
| Contact | Rob Hopkins |
| Correspondent | Rob Hopkins METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-21 |
| Decision Date | 2001-06-12 |