TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)— 510(k) K230140
Substantially EquivalentCompai Healthcare (Suzhou) Co.,Ltd
FDA 510(k) clearance K230140 for TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US), Substantially Equivalent on 2023-04-24. Applicant: Compai Healthcare (Suzhou) Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Compai Healthcare (Suzhou) Co.,Ltd
- Product code
- Code MWP
- Device class
- Class 2
- Regulation
- 21 CFR 892.1680
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code MWP
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