CLAVIS

Stimulator, Nerve, Battery-powered

MEDTRONIC A/S

The following data is part of a premarket notification filed by Medtronic A/s with the FDA for Clavis.

Pre-market Notification Details

• Device ID: K062478
• 510k Number: K062478
• Device Name: CLAVIS
• Classification: Stimulator, Nerve, Battery-powered
• Applicant: MEDTRONIC A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740
• Contact: Ann-christine Provoost
• Correspondent: Ann-christine Provoost; MEDTRONIC A/S 16-18 TONSBAKKEN Skovlunde, DK Dk-2740
• Product Code: BXN
• CFR Regulation Number: 868.2775 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-24
• Decision Date: 2007-02-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00613994197580	K062478	000
05704736009546	K062478	000
05704736004091	K062478	000
05704736002745	K062478	000
00382830049702	K062478	000