ADVANTAGE

Stimulator, Electrical, Evoked Response

CLARK DAVIS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clark Davis Medical Systems, Inc. with the FDA for Advantage.

Pre-market Notification Details

• Device ID: K885246
• 510k Number: K885246
• Device Name: ADVANTAGE
• Classification: Stimulator, Electrical, Evoked Response
• Applicant: CLARK DAVIS MEDICAL SYSTEMS, INC. 1764 OXFORD ST. London, Ontario, CA N5v 3r6
• Contact: Michael Clark
• Correspondent: Michael Clark; CLARK DAVIS MEDICAL SYSTEMS, INC. 1764 OXFORD ST. London, Ontario, CA N5v 3r6
• Product Code: GWF
• CFR Regulation Number: 882.1870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-12-22
• Decision Date: 1989-02-27