Xbody Newave USA— 510(k) K190038
Substantially EquivalentXbody Hungary Kft.
FDA 510(k) clearance K190038 for Xbody Newave USA, Substantially Equivalent on 2019-04-05. Applicant: Xbody Hungary Kft.. Device class: 2.
Clearance details
- Applicant
- Xbody Hungary Kft.
- 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
- Budapest, HU
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