COMPASS

Ophthalmoscope, Laser, Scanning

CENTERVUE SPA

The following data is part of a premarket notification filed by Centervue Spa with the FDA for Compass.

Pre-market Notification Details

• Device ID: K150320
• 510k Number: K150320
• Device Name: COMPASS
• Classification: Ophthalmoscope, Laser, Scanning
• Applicant: CENTERVUE SPA VIA SAN MARCO, 9H Padova, IT 35129
• Contact: Roberto Gabriotti
• Correspondent: Roberto Gabriotti; CENTERVUE SPA VIA SAN MARCO, 9H Padova, IT 35129
• Product Code: MYC
• CFR Regulation Number: 886.1570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-09
• Decision Date: 2015-06-30
• Summary: summary