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510(k) K191700

Device
EyeStat
Applicant
Blinktbi Inc.
510(k) number
K191700
Product code
GZP  
Decision
Substantially Equivalent (SESE)
Decision date
2019-12-09
Date received
2019-06-25
Regulation
882.1880
Classification name
Stimulator, Mechanical, Evoked Response
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ryan Fiorini
Address
635 Rutledge Ave., Suite 102 Charleston SC US 29403 29403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GZP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K913604SOMATOSENSORY STIMULUS SYSTEMBiomagnetic Technologies, Inc.1991-12-09

Legacy Summary#

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FDA Review#

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