KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS— 510(k) K945964
Substantially Equivalent - Subject to Tracking Reg.Sherwood Medical Co.
FDA 510(k) clearance K945964 for KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS, Substantially Equivalent - Subject to Tracking Reg. on 1995-03-07. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- Product code
- Code LZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- St. Joseph, MO, US
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Adverse events under product code LZH
product code LZH- Death
- 12
- Malfunction
- 4,186
- Total
- 4,198
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.