THE EXPERT MODELS RTS 2000 AND RTS 2000H— 510(k) K862947

Name: FDA 510(k) clearance K862947
Creator: U.S. Food and Drug Administration
Published: 1987-11-04

Substantially Equivalent

Ocg Technology, Inc.

FDA 510(k) clearance K862947 for THE EXPERT MODELS RTS 2000 AND RTS 2000H, Substantially Equivalent on 1987-11-04. Applicant: Ocg Technology, Inc.. Device class: 2.

Clearance details

Applicant: Ocg Technology, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1986-08-05
Decision date: 1987-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

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K863153 — MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH1987-01-06
K812971 — CARDIOINTEGRAM1981-12-29

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.