MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE— 510(k) K970051
Substantially EquivalentSmith and Nephew Donjoy, Inc.
FDA 510(k) clearance K970051 for MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE, Substantially Equivalent on 1997-07-10. Applicant: Smith and Nephew Donjoy, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith and Nephew Donjoy, Inc.
- Product code
- Code HCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carsbad, CA, US
Recent devices under product code HCC
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