CL24N
FDA 510(k) clearance K222717 · decided 2022-10-31
Clearance details
- K-number
- K222717
- Device name
- CL24N
- Applicant
- Wide Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-09-08
- Decision date
- 2022-10-31
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hwaseong-Si, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.