SIGMA 8000 AND SIGMA 8002— 510(k) K950766
Substantially EquivalentSigma Intl. General Medical Apparatus, Inc.
FDA 510(k) clearance K950766 for SIGMA 8000 AND SIGMA 8002, Substantially Equivalent on 1995-03-22. Applicant: Sigma Intl. General Medical Apparatus, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Intl. General Medical Apparatus, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medina, NY, US
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Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
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.