INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K— 510(k) K002739
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K002739 for INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K, Substantially Equivalent on 2000-09-11. Applicant: Baxter Healthcare Corp. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Round Lake, IL, US
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Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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.