NORAV HOLTER SYSTEM, MODEL NH-300 V1.07— 510(k) K012712

Name: FDA 510(k) clearance K012712
Creator: U.S. Food and Drug Administration
Published: 2002-05-08

Substantially Equivalent

Norav Medical , Ltd.

FDA 510(k) clearance K012712 for NORAV HOLTER SYSTEM, MODEL NH-300 V1.07, Substantially Equivalent on 2002-05-08. Applicant: Norav Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Norav Medical , Ltd.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2001-08-14
Decision date: 2002-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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