FDA 510(k)

OEC Elite

K-Number: K170752 · 2017-05-19

Decision Date2017-05-19

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OEC Elite is the device name listed in this FDA 510(k) record. The listed applicant is Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-05-19 under 510(k) 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. The listed applicant is Oec Medical Systems, Inc.. The 510(k) number is K170752.

When did OEC Elite receive FDA 510(k) clearance?

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

Who is the listed applicant for OEC Elite?

The FDA 510(k) record lists Oec Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OEC Elite?

The FDA product code for OEC Elite is OWB.

Related Devices (Code: OWB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

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.