HOCA EZ-CARE BP108, TENDER-CARE BP109— 510(k) K052671

Substantially Equivalent

Hoca Medical Microsystem, Inc.

FDA 510(k) clearance K052671 for HOCA EZ-CARE BP108, TENDER-CARE BP109, Substantially Equivalent on 2006-02-03. Applicant: Hoca Medical Microsystem, Inc..

Clearance details

Applicant: Hoca Medical Microsystem, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2005-09-27
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

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.