The following data is part of a premarket notification filed by Spinematrix, Inc. with the FDA for Cersr Electromyography System.
| Device ID | K110048 |
| 510k Number | K110048 |
| Device Name: | CERSR ELECTROMYOGRAPHY SYSTEM |
| Classification | Electromyograph, Diagnostic |
| Applicant | SPINEMATRIX, INC. 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SPINEMATRIX, INC. 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | IKN |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-06 |
| Decision Date | 2011-01-26 |
| Summary: | summary |