6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
FDA 510(k) clearance K212105 · decided 2021-08-23
Clearance details
- K-number
- K212105
- Device name
- 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
- Applicant
- Pzmedical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-06
- Decision date
- 2021-08-23
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- MQB
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.