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
Download summary PDFView on FDA.gov ↗

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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.