Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OEC Elite

K-Number: K170752 · 2017-05-19

ApplicantOec Medical Systems, Inc.
Decision Date2017-05-19
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OEC Elite is a medical device manufactured by Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K170752. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OEC Elite?

OEC Elite is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Oec Medical Systems, Inc.. The 510(k) number is K170752.

When was OEC Elite approved by the FDA?

OEC Elite received FDA 510(k) clearance on 2017-05-19, under approval number K170752.

What company makes OEC Elite?

OEC Elite is manufactured by Oec Medical Systems, Inc..

What is the FDA product code for OEC Elite?

The FDA product code for OEC Elite is OWB.

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162148Allura Xper R9Philips Medical Systems Nethrlands BV K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑