FILTRARE TM ALLVENT TM— 510(k) K834376

Substantially Equivalent

Alltek, Inc.

FDA 510(k) clearance K834376 for FILTRARE TM ALLVENT TM, Substantially Equivalent on 1984-05-11. Applicant: Alltek, Inc..

Clearance details

Applicant: Alltek, Inc.
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1983-12-14
Decision date: 1984-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.