OEC Elite

Interventional Fluoroscopic X-ray System

OEC Medical Systems, Inc.

The following data is part of a premarket notification filed by Oec Medical Systems, Inc. with the FDA for Oec Elite.

Pre-market Notification Details

• Device ID: K170752
• 510k Number: K170752
• Device Name: OEC Elite
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116
• Contact: Helen Peng
• Correspondent: Helen Peng; OEC Medical Systems, Inc. 384 Wright Brothers Drive Salt Lake City, UT 84116
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-13
• Decision Date: 2017-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840682121729	K170752	000