EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML— 510(k) K001287
Substantially EquivalentSorenson Medical, Inc.
FDA 510(k) clearance K001287 for EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML, Substantially Equivalent on 2000-06-09. Applicant: Sorenson Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorenson Medical, Inc.
- Product code
- Code KPE
- Device class
- Class 2
- Regulation
- 21 CFR 880.5025
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Jordan, UT, US
Recent devices under product code KPE
view allMore clearances from Sorenson Medical, Inc.
view all- K052221 — AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
- K033325 — AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
- K033425 — AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
- K002434 — PALM PUMP
- 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 KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.