Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
FDA 510(k) clearance K203652 · decided 2021-01-06
Clearance details
- K-number
- K203652
- Device name
- Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
- Applicant
- Jkh USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-12-14
- Decision date
- 2021-01-06
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- DXQ
- Device class
- 2
- Regulation number
- 870.1120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walnut, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.