510(k) K813319— ASPIRATOR VENTURI SYSTEM MODEL 55-JV

Substantially Equivalent

J. H. Emerson Co.

Clearance details

Applicant: J. H. Emerson Co.
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1981-11-24
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.