Classic

Device, Anti-snoring

Orthoapnea S.L.

The following data is part of a premarket notification filed by Orthoapnea S.l. with the FDA for Classic.

Pre-market Notification Details

• Device ID: K203477
• 510k Number: K203477
• Device Name: Classic
• Classification: Device, Anti-snoring
• Applicant: Orthoapnea S.L. C / Flauta Magica 22 Malaga, ES 29006
• Contact: Jose Repolles Llecha
• Correspondent: Jose Repolles Llecha; Orthoapnea S.L. C / Flauta Magica 22 Malaga, ES 29006
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-27
• Decision Date: 2021-02-25