510(k) K193627 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Automatic Upper Arm Blood Pressure Monitor
| Applicant | Dongguan E-Test Technology Co., Ltd., Dongguan, CN |
| Decision | Substantially Equivalent, Jul 12, 2020 |
| Received | Dec 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193627
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 Open, Classified |
DXN | None listed |
| Oct 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U. Open, Classified |
DXN | None listed |
| Oct 8, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT. Open, Classified |
DXN | None listed |
| Apr 1, 2024 | MEDLINE INDUSTRIES, LP - Northfield Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS Open, Classified |
DXN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.