TaiChiA
FDA 510(k) clearance K193207 · decided 2020-08-07
Clearance details
- K-number
- K193207
- Device name
- TaiChiA
- Applicant
- Our United Corporation
- Decision
- Substantially Equivalent
- Date received
- 2019-11-20
- Decision date
- 2020-08-07
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Xi'An, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.