MULTISTIM

Stimulator, Muscle, Powered

METRON MEDICAL AUSTRALIA PTY LTD

The following data is part of a premarket notification filed by Metron Medical Australia Pty Ltd with the FDA for Multistim.

Pre-market Notification Details

• Device ID: K132137
• 510k Number: K132137
• Device Name: MULTISTIM
• Classification: Stimulator, Muscle, Powered
• Applicant: METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201
• Contact: David Mitchell
• Correspondent: David Mitchell; METRON MEDICAL AUSTRALIA PTY LTD 57 ASTER AVE. Carrum Downs, Victoria, AU 3201
• Product Code: IPF
• Subsequent Product Code: GZJ
• Subsequent Product Code: LIH
• CFR Regulation Number: 890.5850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-07-11
• Decision Date: 2013-09-12