The following data is part of a premarket notification filed by Jkh Usa, Llc with the FDA 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,.
| Device ID | K203652 |
| 510k 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, |
| Classification | Blood Pressure Cuff |
| Applicant | JKH USA, LLC 20505 Valley Blvd. Suite 108 Walnut, CA 91789 |
| Contact | Bill Quanqin Dai |
| Correspondent | Bill Quanqin Dai JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-14 |
| Decision Date | 2021-01-06 |