Arm Blood Pressure Monitor— 510(k) K222869
Substantially EquivalentAndon Health Co, Ltd.
FDA 510(k) clearance K222869 for Arm Blood Pressure Monitor, Substantially Equivalent on 2023-02-15. Applicant: Andon Health Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Andon Health Co, 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
- Abbreviated
- Location
- Tianjin, CN
Recent devices under product code DXN
view all- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- 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)
More clearances from Andon Health Co, Ltd.
view all- K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C) +9 more
- K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
- K234041 — Fully Automatic Electronic Blood Pressure Monitor (7 models)
- K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
- K212598 — iHealth infrared Ear thermometer PT5
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.