Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)— 510(k) K261082
Substantially EquivalentMicrolife Corporation
FDA 510(k) clearance K261082 for Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G), Substantially Equivalent on 2026-07-23. Applicant: Microlife Corporation. Device class: 2.
Clearance details
- Applicant
- Microlife Corporation
- Product code
- Code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei, CN
Recent devices under product code DXN
view allMore clearances from Microlife Corporation
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.