Serenity

Masker, Tinnitus

SANUTHERA, INC.

The following data is part of a premarket notification filed by Sanuthera, Inc. with the FDA for Serenity.

Pre-market Notification Details

• Device ID: K150014
• 510k Number: K150014
• Device Name: Serenity
• Classification: Masker, Tinnitus
• Applicant: SANUTHERA, INC. 340 WEST STATE STREET, UNIT 45 Athens, OH 45701
• Contact: Jeffery Digiovanni
• Correspondent: Jeffery Digiovanni; SANUTHERA, INC. 340 WEST STATE STREET, UNIT 45 Athens, OH 45701
• Product Code: KLW
• CFR Regulation Number: 874.3400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-05
• Decision Date: 2015-07-27
• Summary: summary