DEVILBISS SUCTION UNIT— 510(k) K982304

Substantially Equivalent

Sunrise Medical Hhg, Inc.

FDA 510(k) clearance K982304 for DEVILBISS SUCTION UNIT, Substantially Equivalent on 1998-09-25. Applicant: Sunrise Medical Hhg, Inc..

Clearance details

Applicant: Sunrise Medical Hhg, Inc.
Product code: 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

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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.