BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5— 510(k) K081026
Substantially EquivalentSport-Elec S.A.
FDA 510(k) clearance K081026 for BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5, Substantially Equivalent on 2008-11-05. Applicant: Sport-Elec S.A.. Device class: 2.
Clearance details
- Applicant
- Sport-Elec S.A.
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hampton, VA, US
Recent devices under product code NGX
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