TRUEFIELD ANALYZER— 510(k) K063310

Substantially Equivalent

Seeing Machines Limited

FDA 510(k) clearance K063310 for TRUEFIELD ANALYZER, Substantially Equivalent on 2007-08-02. Applicant: Seeing Machines Limited. Device class: 1.

Clearance details

Applicant: Seeing Machines Limited
Product code: Code HPT
Device class: Class 1
Regulation: 21 CFR 886.1605
Advisory panel: Ophthalmic
Date received: 2006-11-02
Decision date: 2007-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.