K120035

Substantially Equivalent

APEX MEDICAL ICH CPAP SERIES (9S-007XXX)

Applicant: Apex Medical Corp.
Product code: BZD
Advisory panel: Anesthesiology
Date received: 2012-01-04
Decision date: 2012-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Tucheng City, Taipei County, TW

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.