PANOPTIC

Camera, Ophthalmic, Ac-powered

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Panoptic.

Pre-market Notification Details

• Device ID: K121405
• 510k Number: K121405
• Device Name: PANOPTIC
• Classification: Camera, Ophthalmic, Ac-powered
• Applicant: WELCH ALLYN, INC. 4341 STATE ST. RD. PO BOX 220 Skaneateles Falls, NY 13153 -0020
• Contact: Kevin Crossen
• Correspondent: Kevin Crossen; WELCH ALLYN, INC. 4341 STATE ST. RD. PO BOX 220 Skaneateles Falls, NY 13153 -0020
• Product Code: HKI
• CFR Regulation Number: 886.1120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-05-10
• Decision Date: 2012-12-20
• Summary: summary