ASCEND

Stimulator, Nerve, Battery-powered

NEUROMETRIX, INC.

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

Pre-market Notification Details

• Device ID: K091155
• 510k Number: K091155
• Device Name: ASCEND
• Classification: Stimulator, Nerve, Battery-powered
• Applicant: NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451
• Contact: Rainer Maas
• Correspondent: Rainer Maas; NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451
• Product Code: BXN
• CFR Regulation Number: 868.2775 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-21
• Decision Date: 2009-09-03
• Summary: summary