OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500— 510(k) K081094
Substantially EquivalentOlympic Medical Corp.
FDA 510(k) clearance K081094 for OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500, Substantially Equivalent on 2008-06-20. Applicant: Olympic Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Olympic Medical Corp.
- Product code
- Code MEC
- Device class
- Class 2
- Regulation
- 21 CFR 880.6992
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seattle, WA, US
Recent devices under product code MEC
view allMore clearances from Olympic Medical Corp.
view allAdverse events under product code MEC
product code MEC- Malfunction
- 483
- Other
- 1
- Total
- 484
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K081094
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081094.
Data sourced from openFDA. This site is unofficial and independent of the FDA.