ALES

Aid, Vision, Electronic, Battery-powered

OMS

The following data is part of a premarket notification filed by Oms with the FDA for Ales.

Pre-market Notification Details

• Device ID: K823385
• 510k Number: K823385
• Device Name: ALES
• Classification: Aid, Vision, Electronic, Battery-powered
• Applicant: OMS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: HPG
• CFR Regulation Number: 886.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-11-15
• Decision Date: 1983-03-09