VIVOSIGHT TOPICAL OCT SYSTEM— 510(k) K093520

Name: FDA 510(k) clearance K093520
Creator: U.S. Food and Drug Administration
Published: 2010-01-05

Substantially Equivalent

Michelson Diagnostics, Ltd.

FDA 510(k) clearance K093520 for VIVOSIGHT TOPICAL OCT SYSTEM, Substantially Equivalent on 2010-01-05. Applicant: Michelson Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Michelson Diagnostics, Ltd.
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2009-11-13
Decision date: 2010-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orpington, Kent, GB

Download summary PDF View on FDA.gov ↗

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