OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500— 510(k) K081094

Substantially Equivalent

Olympic Medical Corp.

FDA 510(k) clearance K081094 for OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500, Substantially Equivalent on 2008-06-20. Applicant: Olympic Medical Corp..

Clearance details

Applicant: Olympic Medical Corp.
Product code: Code MEC
Advisory panel: General Hospital
Date received: 2008-04-17
Decision date: 2008-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEC

product code MEC

Malfunction: 483
Other: 1
Total: 484

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.