TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM— 510(k) K101861

Name: FDA 510(k) clearance K101861
Creator: U.S. Food and Drug Administration
Published: 2010-12-22

Substantially Equivalent

Truevision Systems, Incorporated

FDA 510(k) clearance K101861 for TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM, Substantially Equivalent on 2010-12-22. Applicant: Truevision Systems, Incorporated. Device class: 2.

Clearance details

Applicant: Truevision Systems, Incorporated
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2010-07-02
Decision date: 2010-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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