MACULOSCOPE(TM)

Stimulator, Photic, Evoked Response

DORAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Doran Instruments, Inc. with the FDA for Maculoscope(tm).

Pre-market Notification Details

• Device ID: K863956
• 510k Number: K863956
• Device Name: MACULOSCOPE(TM)
• Classification: Stimulator, Photic, Evoked Response
• Applicant: DORAN INSTRUMENTS, INC. 410 GREAT RD. P.O. BOX 1070 Littleton, MA 01460
• Contact: Bruce Doran
• Correspondent: Bruce Doran; DORAN INSTRUMENTS, INC. 410 GREAT RD. P.O. BOX 1070 Littleton, MA 01460
• Product Code: GWE
• CFR Regulation Number: 882.1890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-10
• Decision Date: 1986-11-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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