DeviceClearance

BODYGUARD INFUSION PUMP SYSTEM— 510(k) K042696

Substantially Equivalent

Caesarea Medical Electronics , Ltd.

FDA 510(k) clearance K042696 for BODYGUARD INFUSION PUMP SYSTEM, Substantially Equivalent on 2005-03-11. Applicant: Caesarea Medical Electronics , Ltd.. Device class: 2.

Clearance details

Applicant
Caesarea Medical Electronics , Ltd.
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
Traditional
Location
Caesarea, IL
Download summary PDFView on FDA.gov ↗

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More clearances from Caesarea Medical Electronics , Ltd.

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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 →

Recalls naming K042696

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042696.

Data sourced from openFDA. This site is unofficial and independent of the FDA.