SMARTSCOPE

Device, Nerve Conduction Velocity Measurement

INSIGHT MEDICAL CORP.

The following data is part of a premarket notification filed by Insight Medical Corp. with the FDA for Smartscope.

Pre-market Notification Details

• Device ID: K932533
• 510k Number: K932533
• Device Name: SMARTSCOPE
• Classification: Device, Nerve Conduction Velocity Measurement
• Applicant: INSIGHT MEDICAL CORP. 173 FAIRVIEW AVENUE Toronto, Ontario, CA M6p 3a6
• Contact: Richard Mcmullin
• Correspondent: Richard Mcmullin; INSIGHT MEDICAL CORP. 173 FAIRVIEW AVENUE Toronto, Ontario, CA M6p 3a6
• Product Code: JXE
• CFR Regulation Number: 882.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-05-26
• Decision Date: 1994-03-31