The following data is part of a premarket notification filed by Fasstech with the FDA for Insight Millennium Iii.
| Device ID | K023209 |
| 510k Number | K023209 |
| Device Name: | INSIGHT MILLENNIUM III |
| Classification | Electromyograph, Diagnostic |
| Applicant | FASSTECH 76 TREBLE COVE RD. BUILDING #2 North Billerica, MA 01862 |
| Contact | Lee Brody |
| Correspondent | Lee Brody FASSTECH 76 TREBLE COVE RD. BUILDING #2 North Billerica, MA 01862 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-26 |
| Decision Date | 2003-10-10 |
| Summary: | summary |