SACCADOMETER PLUS, SACCADOMETER ADVANCED— 510(k) K152890

Name: FDA 510(k) clearance K152890
Creator: U.S. Food and Drug Administration
Published: 2016-08-11

Substantially Equivalent

Ober Consulting Sp. Z.O.O.

FDA 510(k) clearance K152890 for SACCADOMETER PLUS, SACCADOMETER ADVANCED, Substantially Equivalent on 2016-08-11. Applicant: Ober Consulting Sp. Z.O.O.. Device class: 2.

Clearance details

Applicant: Ober Consulting Sp. Z.O.O.
Product code: Code HLL
Device class: Class 2
Regulation: 21 CFR 886.1510
Advisory panel: Ophthalmic
Date received: 2015-09-30
Decision date: 2016-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poznan, PL

Download summary PDF View on FDA.gov ↗

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