COULTER MH025A— 510(k) K950949
Substantially EquivalentCoulter Corp.
FDA 510(k) clearance K950949 for COULTER MH025A, Substantially Equivalent on 1995-07-20. Applicant: Coulter Corp.. Device class: 2.
Clearance details
- Applicant
- Coulter Corp.
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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.