CARDIOSPY ECG HOLTER SYSTEMS— 510(k) K140847

Substantially Equivalent

Labtech Kft.

FDA 510(k) clearance K140847 for CARDIOSPY ECG HOLTER SYSTEMS, Substantially Equivalent on 2014-12-05. Applicant: Labtech Kft.. Device class: 2.

Clearance details

Applicant: Labtech Kft.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2014-04-03
Decision date: 2014-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Debrecen, HU

Download summary PDF View on FDA.gov ↗

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