AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)— 510(k) K092432

Substantially Equivalent

Jawon Medical Co., Ltd.

FDA 510(k) clearance K092432 for AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L), Substantially Equivalent on 2009-10-09. Applicant: Jawon Medical Co., Ltd..

Clearance details

Applicant: Jawon Medical Co., Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2009-08-07
Decision date: 2009-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Kyungsan-City, Kyungsan-Bukdo, KR

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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, 2020-01-01 through 2026-04-23. 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.