BU-CAD— 510(k) K210670
Substantially EquivalentTaihao Medical, Inc.
FDA 510(k) clearance K210670 for BU-CAD, Substantially Equivalent on 2021-12-21. Applicant: Taihao Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Taihao Medical, Inc.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, TW
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