The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Musclesense Ii Clinical Electromyography Device.
| Device ID | K970051 |
| 510k Number | K970051 |
| Device Name: | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE |
| Classification | Device, Biofeedback |
| Applicant | SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Contact | Dan W Miller |
| Correspondent | Dan W Miller SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-07 |
| Decision Date | 1997-07-10 |
| Summary: | summary |