CARE MODEL IP 4500 AUTO SCANNERR— 510(k) K821015

Name: FDA 510(k) clearance K821015
Creator: U.S. Food and Drug Administration
Published: 1982-05-24

Substantially Equivalent

Care Monitoring Systems

FDA 510(k) clearance K821015 for CARE MODEL IP 4500 AUTO SCANNERR, Substantially Equivalent on 1982-05-24. Applicant: Care Monitoring Systems. Device class: 2.

Clearance details

Applicant: Care Monitoring Systems
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1982-04-12
Decision date: 1982-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K842582 — CARE 5000 CENTRAL MONITOR MS5220 ETC.1984-12-11

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.