Besmed PEEP Valve— 510(k) K160112

Substantially Equivalent

Besmed Health Business Corp

FDA 510(k) clearance K160112 for Besmed PEEP Valve, Substantially Equivalent on 2016-04-29. Applicant: Besmed Health Business Corp.

Clearance details

Applicant: Besmed Health Business Corp
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 2016-01-19
Decision date: 2016-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYE

product code BYE

Death: 5
Total: 5

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.