The following data is part of a premarket notification filed by Fasstech with the FDA for Cwas 1000.
| Device ID | K033452 |
| 510k Number | K033452 |
| Device Name: | CWAS 1000 |
| Classification | Electromyograph, Diagnostic |
| Applicant | FASSTECH 76 TREBLE COVE RD. BUILDING #2 North Billerica, MA 01862 |
| Contact | Lee Brody |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-10-30 |
| Decision Date | 2003-11-28 |
| Summary: | summary |