FETH-R-KATH— 510(k) K981329

Substantially Equivalent

Epimed International, Inc.

FDA 510(k) clearance K981329 for FETH-R-KATH, Substantially Equivalent on 1998-08-26. Applicant: Epimed International, Inc..

Clearance details

Applicant: Epimed International, Inc.
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 1998-04-13
Decision date: 1998-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloversville, NY, US

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.