0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS— 510(k) K935641

Substantially Equivalent

Evans Medical, Inc.

FDA 510(k) clearance K935641 for 0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS, Substantially Equivalent on 1994-01-28. Applicant: Evans Medical, Inc..

Clearance details

Applicant: Evans Medical, Inc.
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1993-11-22
Decision date: 1994-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pineville, PA, US

Download summary PDF View on FDA.gov ↗

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.