PREMIER 11 HOLTER— 510(k) K062088

Name: FDA 510(k) clearance K062088
Creator: U.S. Food and Drug Administration
Published: 2006-08-25

Substantially Equivalent

Diagnostic Monitoring Software

FDA 510(k) clearance K062088 for PREMIER 11 HOLTER, Substantially Equivalent on 2006-08-25. Applicant: Diagnostic Monitoring Software. Device class: 2.

Clearance details

Applicant: Diagnostic Monitoring Software
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2006-07-24
Decision date: 2006-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Stateline, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MLO

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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

More clearances from Diagnostic Monitoring Software

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K133014 — DMS 300-2W HOLTER ECG RECORDER2014-05-19
K062959 — DMS 300-2, 300-3 AND 300-42006-10-16
K062007 — DMS 300-72006-08-16
K911615 — HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 3001992-01-08

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