INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM— 510(k) K002380
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K002380 for INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM, Substantially Equivalent on 2000-09-05. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- 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
- Round Lake, IL, 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.