WESTMED CIRCULARIE PEP DEVICES— 510(k) K955047

Substantially Equivalent

Westmed Intl.

FDA 510(k) clearance K955047 for WESTMED CIRCULARIE PEP DEVICES, Substantially Equivalent on 1996-03-27. Applicant: Westmed Intl..

Clearance details

Applicant: Westmed Intl.
Product code: Code BYE
Advisory panel: Anesthesiology
Date received: 1995-11-03
Decision date: 1996-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

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.