Spectrum IQ Infusion System, Dose IQ Safety Software— 510(k) K173084
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K173084 for Spectrum IQ Infusion System, Dose IQ Safety Software, Substantially Equivalent on 2018-05-11. Applicant: Baxter Healthcare Corporation.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Lake, IL, US
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.