GALAXY

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

LARSEN & TOUBRO LIMITED

The following data is part of a premarket notification filed by Larsen & Toubro Limited with the FDA for Galaxy.

Pre-market Notification Details

• Device ID: K061816
• 510k Number: K061816
• Device Name: GALAXY
• Classification: Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
• Applicant: LARSEN & TOUBRO LIMITED 1821 WALDEN OFFICE SQUARE SUITE 400 Schaumburg, IL 60173
• Contact: Harry P Gugnani
• Correspondent: Daniel W Lehtonen; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: MWI
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-06-28
• Decision Date: 2006-07-12
• Summary: summary