CARDIONAVIGATOR +— 510(k) K051960

Name: FDA 510(k) clearance K051960
Creator: U.S. Food and Drug Administration
Published: 2005-08-19

Substantially Equivalent

Del Mar Reynolds Medical, Ltd.

FDA 510(k) clearance K051960 for CARDIONAVIGATOR +, Substantially Equivalent on 2005-08-19. Applicant: Del Mar Reynolds Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Del Mar Reynolds Medical, Ltd.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 2005-07-19
Decision date: 2005-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

Download summary PDF View on FDA.gov ↗

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