ECOM™ Cardiac Output Monitoring System

Plethysmograph, Impedance

ECOM Medical, Inc

The following data is part of a premarket notification filed by Ecom Medical, Inc with the FDA for Ecom™ Cardiac Output Monitoring System.

Pre-market Notification Details

• Device ID: K172196
• 510k Number: K172196
• Device Name: ECOM™ Cardiac Output Monitoring System
• Classification: Plethysmograph, Impedance
• Applicant: ECOM Medical, Inc 27127 Calle Arroyo, Suite 1905 San Juan Capistrano, CA 92675
• Contact: Guy Lowery
• Correspondent: Cheryl Blake; CHERYL BLAKE 27392 CAPRICHO Mission Viejo, CA 92692
• Product Code: DSB
• CFR Regulation Number: 870.2770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-07-21
• Decision Date: 2017-09-19
• Summary: summary