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

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..

Clearance details

Applicant: Ocg Technology, Inc.
Product code: Code DSI
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 ↗

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.