510(k) K970051
K970051 is an FDA 510(k) premarket notification submitted by Smith And Nephew Donjoy, Inc. for the device "MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE". The FDA issued a decision of Substantially Equivalent on Jul 10, 1997. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Smith And Nephew Donjoy, Inc. has 14 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 10, 1997
- Date Received
- Jan 7, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Biofeedback
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type
- 510(k) Exempt