PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032— 510(k) K033894
Substantially EquivalentMatsushita Electric Works, Ltd.
FDA 510(k) clearance K033894 for PANASONIC WRIST BLOOD PRESSURE MONITOR, MODELS EW 3031 AND EW 3032, Substantially Equivalent on 2004-03-11. Applicant: Matsushita Electric Works, Ltd.. Device class: 2.
Clearance details
- Applicant
- Matsushita Electric Works, Ltd.
- Product code
- Product 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
- Great Neck, NY, US
Recent devices under product code DXN
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- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Matsushita Electric Works, Ltd.
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.