NH-301 AMBULATORY ECG ANALYSIS SOFTWARE— 510(k) K111487

Name: FDA 510(k) clearance K111487
Creator: U.S. Food and Drug Administration
Published: 2011-11-10

Substantially Equivalent

Norav Medical Corp.

FDA 510(k) clearance K111487 for NH-301 AMBULATORY ECG ANALYSIS SOFTWARE, Substantially Equivalent on 2011-11-10. Applicant: Norav Medical Corp.. Device class: 2.

Clearance details

Applicant: Norav Medical Corp.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2011-05-31
Decision date: 2011-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Mitzpe Aviv, IL

Download summary PDF View on FDA.gov ↗

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