ORIEL

Ophthalmoscope, Battery-powered

TRUPHATEK, LTD.

The following data is part of a premarket notification filed by Truphatek, Ltd. with the FDA for Oriel.

Pre-market Notification Details

• Device ID: K920272
• 510k Number: K920272
• Device Name: ORIEL
• Classification: Ophthalmoscope, Battery-powered
• Applicant: TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106
• Contact: Emanuel A Rosen
• Correspondent: Emanuel A Rosen; TRUPHATEK, LTD. P.O. BOX 8051 Netanya, IL 42106
• Product Code: HLJ
• CFR Regulation Number: 886.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-01-22
• Decision Date: 1992-07-09