K982304

Substantially Equivalent

DEVILBISS SUCTION UNIT

Applicant: Sunrise Medical Hhg, Inc.
Product code: JCX
Advisory panel: General, Plastic Surgery
Date received: 1998-07-01
Decision date: 1998-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, PA, US

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.