The following data is part of a premarket notification filed by Fasstech with the FDA for Insight Millennium Plus.
| Device ID | K011964 |
| 510k Number | K011964 |
| Device Name: | INSIGHT MILLENNIUM PLUS |
| Classification | Device, Biofeedback |
| Applicant | FASSTECH 155 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Contact | Lee Brody |
| Correspondent | Lee Brody FASSTECH 155 MIDDLESEX TURNPIKE Burlington, MA 01803 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-25 |
| Decision Date | 2001-09-20 |
| Summary: | summary |