CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM— 510(k) K011345

Name: FDA 510(k) clearance K011345
Creator: U.S. Food and Drug Administration
Published: 2001-07-20

Substantially Equivalent

Reynolds Medical , Ltd.

FDA 510(k) clearance K011345 for CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM, Substantially Equivalent on 2001-07-20. Applicant: Reynolds Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Reynolds Medical , Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2001-05-02
Decision date: 2001-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck, NJ, US

Download summary PDF View on FDA.gov ↗

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