FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER— 510(k) K860605
Substantially EquivalentMigada, Ltd.
FDA 510(k) clearance K860605 for FILTER SET 1) 1.2 MIC FILTER 2) 3.0 MIC FILTER, Substantially Equivalent on 1986-03-24. Applicant: Migada, Ltd.. Device class: 2.
Clearance details
- Applicant
- Migada, Ltd.
- Product code
- Product code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Israel, IL
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More clearances from Migada, Ltd.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.