HD80 Series Ultrasound Diagnostic System
FDA 510(k) clearance K233841 · decided 2024-05-16
Clearance details
- K-number
- K233841
- Device name
- HD80 Series Ultrasound Diagnostic System
- Applicant
- Qingdao Hisense Medical Equipment Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-04
- Decision date
- 2024-05-16
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Qingdao, Shandong, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.