PALM PUMP— 510(k) K002434
Substantially EquivalentSorenson Medical, Inc.
FDA 510(k) clearance K002434 for PALM PUMP, Substantially Equivalent on 2000-08-23. Applicant: Sorenson Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorenson Medical, Inc.
- 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
- West Jordan, UT, US
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More clearances from Sorenson Medical, Inc.
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- K033425 — AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
- K001287 — EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
- K991363 — 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU
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.