AcQMap High Resolution Imaging And Mapping System

Computer, Diagnostic, Programmable

Acutus Medical, Inc.

The following data is part of a premarket notification filed by Acutus Medical, Inc. with the FDA for Acqmap High Resolution Imaging And Mapping System.

Pre-market Notification Details

• Device ID: K170948
• 510k Number: K170948
• Device Name: AcQMap High Resolution Imaging And Mapping System
• Classification: Computer, Diagnostic, Programmable
• Applicant: Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008
• Contact: Brenda Clay
• Correspondent: Brenda Clay; Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008
• Product Code: DQK
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 870.1425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-30
• Decision Date: 2017-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857042007135	K170948	000
00857042007036	K170948	000
00857042007043	K170948	000
00857042007050	K170948	000
00857042007067	K170948	000
00857042007074	K170948	000
00857042007081	K170948	000
00857042007098	K170948	000
00857042007104	K170948	000
00857042007111	K170948	000
00857042007128	K170948	000
00857042007005	K170948	000