AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP— 510(k) K052221
Substantially EquivalentSorenson Medical, Inc.
FDA 510(k) clearance K052221 for AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP, Substantially Equivalent on 2005-12-08. Applicant: Sorenson Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorenson Medical, 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
- Abbreviated
- Location
- West Jordan, UT, US
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More clearances from Sorenson Medical, Inc.
view all- K033325 — AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
- K033425 — AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
- K002434 — PALM 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 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.