ORION

Camera, Ophthalmic, Ac-powered

NIDEK TECHNOLOGIES SRL

The following data is part of a premarket notification filed by Nidek Technologies Srl with the FDA for Orion.

Pre-market Notification Details

• Device ID: K070231
• 510k Number: K070231
• Device Name: ORION
• Classification: Camera, Ophthalmic, Ac-powered
• Applicant: NIDEK TECHNOLOGIES SRL VIA DELL ARTIGIANATO, 6/A Albignasego (padova), IT 35020
• Contact: Aldo Cocchiglia
• Correspondent: Aldo Cocchiglia; NIDEK TECHNOLOGIES SRL VIA DELL ARTIGIANATO, 6/A Albignasego (padova), IT 35020
• Product Code: HKI
• CFR Regulation Number: 886.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-24
• Decision Date: 2007-04-24
• Summary: summary