Ballancer 505 System, Model 1201-AC— 510(k) K150269
Substantially EquivalentMego Afek AC , Ltd.
FDA 510(k) clearance K150269 for Ballancer 505 System, Model 1201-AC, Substantially Equivalent on 2015-05-26. Applicant: Mego Afek AC , Ltd.. Device class: 2.
Clearance details
- Applicant
- Mego Afek AC , Ltd.
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kibbutz Afek, IL
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