DIACARE MONITORING SYSTEM— 510(k) K882001

Name: FDA 510(k) clearance K882001
Creator: U.S. Food and Drug Administration
Published: 1988-10-18

Substantially Equivalent

Healthware Corp.

FDA 510(k) clearance K882001 for DIACARE MONITORING SYSTEM, Substantially Equivalent on 1988-10-18. Applicant: Healthware Corp.. Device class: 2.

Clearance details

Applicant: Healthware Corp.
Product code: Code NDC
Device class: Class 2
Regulation: 21 CFR 868.1890
Advisory panel: Anesthesiology
Date received: 1988-05-12
Decision date: 1988-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NDC

product code NDC

Malfunction: 1,390
Total: 1,390

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.