HD 8Ch Wrist Array
FDA 510(k) clearance K252587 · decided 2026-04-14
Clearance details
- K-number
- K252587
- Device name
- HD 8Ch Wrist Array
- Applicant
- Shenzhen RF Tech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-15
- Decision date
- 2026-04-14
- Days to decision
- 242 days
- Clearance type
- Traditional
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.