SLENDERTONE ENERVIVE, MODEL 561— 510(k) K071666
Substantially EquivalentBio-Medical Research Corp.
FDA 510(k) clearance K071666 for SLENDERTONE ENERVIVE, MODEL 561, Substantially Equivalent on 2008-03-12. Applicant: Bio-Medical Research Corp.. Device class: 2.
Clearance details
- Applicant
- Bio-Medical Research Corp.
- 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
- Galway, IE
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