ICP TRIAGEMANAGER

Transmitters And Receivers, Physiological Signal, Radiofrequency

Emergo Europe Consulting BV

The following data is part of a premarket notification filed by Emergo Europe Consulting Bv with the FDA for Icp Triagemanager.

Pre-market Notification Details

• Device ID: K122095
• 510k Number: K122095
• Device Name: ICP TRIAGEMANAGER
• Classification: Transmitters And Receivers, Physiological Signal, Radiofrequency
• Applicant: Emergo Europe Consulting BV PRINSESSEGRACHT 20 Den Haag, NL 2514
• Contact: Rachida Ziani
• Correspondent: J.a. Van Vugt; DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar
• Product Code: DRG
• CFR Regulation Number: 870.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-07-12
• Decision Date: 2012-07-26
• Summary: summary