ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION— 510(k) K110535
Substantially EquivalentCarefusion 303, Inc.
FDA 510(k) clearance K110535 for ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION, Substantially Equivalent on 2012-03-26. Applicant: Carefusion 303, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 303, 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
- San Diego, CA, US
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More clearances from Carefusion 303, Inc.
view allAdverse 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.