Ballancer Gold, 1212— 510(k) K190015
Substantially EquivalentMego Afek AC , Ltd.
FDA 510(k) clearance K190015 for Ballancer Gold, 1212, Substantially Equivalent on 2019-03-25. 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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