Ova+ (K-OVAP-USA)— 510(k) K230926
Substantially EquivalentTenscare, Ltd.
FDA 510(k) clearance K230926 for Ova+ (K-OVAP-USA), Substantially Equivalent on 2023-12-15. Applicant: Tenscare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Tenscare, Ltd.
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Epsom, GB
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