EPOC BLOOD ANALYSIS SYSTEM— 510(k) K061597

Substantially Equivalent

Epocal, Inc.

FDA 510(k) clearance K061597 for EPOC BLOOD ANALYSIS SYSTEM, Substantially Equivalent on 2006-09-27. Applicant: Epocal, Inc..

Clearance details

Applicant: Epocal, Inc.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2006-06-08
Decision date: 2006-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.