Argos

Computer, Diagnostic, Pre-programmed, Single-function

Retia Medical, LLC

The following data is part of a premarket notification filed by Retia Medical, Llc with the FDA for Argos.

Pre-market Notification Details

• Device ID: K181372
• 510k Number: K181372
• Device Name: Argos
• Classification: Computer, Diagnostic, Pre-programmed, Single-function
• Applicant: Retia Medical, LLC 7 Dana Rd. Suite 111 Valhalla, NY 10595
• Contact: Marc Zemel
• Correspondent: Jerry Korten; Retia Medical, LLC 7 Dana Rd. Suite 111 Valhalla, NY 10595
• Product Code: DXG
• CFR Regulation Number: 870.1435 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-05-23
• Decision Date: 2018-12-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860001506402	K181372	000
00850044487004	K181372	000
00860001506488	K181372	000
00860001506495	K181372	000
00860001506471	K181372	000
00860001506464	K181372	000
00860001506419	K181372	000
00860001506426	K181372	000
00860001506433	K181372	000
00860001506440	K181372	000
00860001506457	K181372	000
00850044487011	K181372	000