CARIOLINE(ELECTROCARDIOGRAPH)— 510(k) K852770

Name: FDA 510(k) clearance K852770
Creator: U.S. Food and Drug Administration
Published: 1985-08-01

Substantially Equivalent

Remco Italia S.P.A.

FDA 510(k) clearance K852770 for CARIOLINE(ELECTROCARDIOGRAPH), Substantially Equivalent on 1985-08-01. Applicant: Remco Italia S.P.A.. Device class: 2.

Clearance details

Applicant: Remco Italia S.P.A.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1985-06-28
Decision date: 1985-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, Italia(Italy), IT

Download summary PDF View on FDA.gov ↗

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K252474 — Withings BeamO (SCT02)2025-11-10
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K032200 — ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH2003-10-03
K032276 — CLICK HOLTER2003-08-27

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.