R.TEST EVOLUTION— 510(k) K993788

Substantially Equivalent

Novacor Div.

FDA 510(k) clearance K993788 for R.TEST EVOLUTION, Substantially Equivalent on 2000-08-04. Applicant: Novacor Div.. Device class: 2.

Clearance details

Applicant: Novacor Div.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1999-11-09
Decision date: 2000-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flemington, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

K261580 — ZBPro Diagnostic (Version 2.0)2026-09-11
K241890 — Philips Holter Analysis System2025-03-21
K240794 — Frontier X Plus2024-11-08
K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System2020-09-02
K193177 — CER-S2020-08-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.