EXPLORER LIVER (PASSIVE TRACKING)— 510(k) K101979

Name: FDA 510(k) clearance K101979
Creator: U.S. Food and Drug Administration
Published: 2011-02-09

Substantially Equivalent

Pathfinder Therapeutics, Inc.

FDA 510(k) clearance K101979 for EXPLORER LIVER (PASSIVE TRACKING), Substantially Equivalent on 2011-02-09. Applicant: Pathfinder Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Pathfinder Therapeutics, Inc.
Product code: Code OEW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2010-07-14
Decision date: 2011-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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