Transducer Probe Cover
FDA 510(k) clearance K221278 · decided 2023-01-11
Clearance details
- K-number
- K221278
- Device name
- Transducer Probe Cover
- Applicant
- Hony Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-03
- Decision date
- 2023-01-11
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Taishan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.