510(k) K152890

Device: SACCADOMETER PLUS, SACCADOMETER ADVANCED
Applicant: OBER CONSULTING SP. Z.O.O.
510(k) number: K152890
Product code: HLL
Decision: Substantially Equivalent (SESE)
Decision date: 2016-08-11
Date received: 2015-09-30
Regulation: 886.1510
Classification name: Monitor, Eye Movement
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JAN KRZYSZTOF OBER
Address: Brzechwy 6 Poznan PL 60-195 60-195

FDA Registration Numbers#

3005785090
3027593072
3003553186
2031962

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
05906874392027	SACCADOMETER	OBER CONSULTING SP Z O O	2017-01-26
05906874392010	SACCADOMETER	OBER CONSULTING SP Z O O	2017-01-26

Other 510(k) Records For Product Code HLL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K222484	Retitrack	C. Light Technologies, Inc.	2023-05-09
K033949	VARILUX VISIONPRINT SYSTEM (VPS)	Essilor Intl.	2004-07-02
K872111	ORTHOTONE	Orthotone Corp.	1988-11-16

Legacy Summary#

summary

FDA Review#

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