DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE— 510(k) K133957

Substantially Equivalent

Galemed Corp.

FDA 510(k) clearance K133957 for DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE, Substantially Equivalent on 2014-04-14. Applicant: Galemed Corp..

Clearance details

Applicant: Galemed Corp.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 2013-12-23
Decision date: 2014-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, Fujian, CN

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.