Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)— 510(k) K253059
Substantially EquivalentTournicare Pty, Ltd.
FDA 510(k) clearance K253059 for Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08), Substantially Equivalent on 2026-06-15. Applicant: Tournicare Pty, Ltd.. Device class: 2.
Clearance details
- Applicant
- Tournicare Pty, Ltd.
- 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
- Balwyn, AU
Recent devices under product code DXN
view all- K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
- K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
- K261061 — BP Go (BPP-855)
- K261082 — Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
- K261136 — Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
Adverse 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.