EchoS

Bone Sonometer

Echolight Spa

The following data is part of a premarket notification filed by Echolight Spa with the FDA for Echos.

Pre-market Notification Details

• Device ID: K180516
• 510k Number: K180516
• Device Name: EchoS
• Classification: Bone Sonometer
• Applicant: Echolight Spa Via Raffaello Sanzio 18 Lecce, IT 73100
• Contact: Sergio Casciaro
• Correspondent: Maurizio Pantaleoni; Isemed Srl Via P. Togliatti 19/X Imola, IT 40026
• Product Code: MUA
• CFR Regulation Number: 892.1180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-27
• Decision Date: 2018-10-19
• Summary: summary