TRAXYLOC-1 SYSTEM— 510(k) K050663

Substantially Equivalent

Traxyz Medical, Inc.

FDA 510(k) clearance K050663 for TRAXYLOC-1 SYSTEM, Substantially Equivalent on 2005-04-08. Applicant: Traxyz Medical, Inc.. Device class: 2.

Clearance details

Applicant: Traxyz Medical, Inc.
Product code: Code IZH
Device class: Class 2
Regulation: 21 CFR 892.1710
Advisory panel: Radiology
Date received: 2005-03-15
Decision date: 2005-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.