Aneroid Sphygmomanometer
FDA 510(k) clearance K230859 · decided 2023-06-28
Clearance details
- K-number
- K230859
- Device name
- Aneroid Sphygmomanometer
- Applicant
- Wenzhou Kangshun Medical Devices Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2023-03-29
- Decision date
- 2023-06-28
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wenzhou City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.