EYE-SYNC

Nystagmograph

SyncThink, Inc.

The following data is part of a premarket notification filed by Syncthink, Inc. with the FDA for Eye-sync.

Pre-market Notification Details

• Device ID: K152915
• 510k Number: K152915
• Device Name: EYE-SYNC
• Classification: Nystagmograph
• Applicant: SyncThink, Inc. 54 Canal Street Suite 200 Boston, MA 02114
• Contact: Daniel Beeler
• Correspondent: Maureen O'connell; O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864
• Product Code: GWN
• CFR Regulation Number: 882.1460 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-10-02
• Decision Date: 2016-01-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00868096000300	K152915	000
00860013612900	K152915	000