AcuPebble OX100— 510(k) K222950
Substantially EquivalentAcurable Limited
FDA 510(k) clearance K222950 for AcuPebble OX100, Substantially Equivalent on 2023-02-03. Applicant: Acurable Limited. Device class: 2.
Clearance details
- Applicant
- Acurable Limited
- Product code
- Code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- London, GB
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