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FDA 510(k)

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

K-Number: K203652 · 2021-01-06

ApplicantJkh USA, LLC
Decision Date2021-01-06
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2021-01-06 under 510(k) number K203652. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2021-01-06. The listed applicant is Jkh USA, LLC. The 510(k) number is K203652.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2021-01-06, under 510(k) number K203652.

Who is the listed applicant for 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?

The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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?

The FDA product code for 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 is DXQ.

Other records listing Jkh USA, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 9 devices →

Related Devices (Code: DXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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