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510(k) K191700

EyeStat by Blinktbi, Inc. — Product Code GZP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 9, 2019
Date Received: June 25, 2019
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stimulator, Mechanical, Evoked Response
Device Class: Class II
Regulation Number: 882.1880
Review Panel: NE
Submission Type