TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN— 510(k) K882825
Substantially EquivalentA&D Engineering, Inc.
FDA 510(k) clearance K882825 for TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN, Substantially Equivalent on 1989-01-17. Applicant: A&D Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- A&D Engineering, Inc.
- 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
- San Jose, CA, US
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 A&D Engineering, Inc.
view all- K082734 — A&D MEDICAL UA-851THW DIGITAL BLOOD PRESSURE MONITOR
- K062027 — A&D MEDICAL UA-789 DIGITAL BLOOD PRESSURE MONITOR
- K061456 — A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR
- K043217 — A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
- K042967 — A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
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.