FDA 510(k)

EBM iDO Viewer 1.2.1

K-Number: K162285 · 2017-01-27

Decision Date2017-01-27

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EBM iDO Viewer 1.2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Ebm Technologies Incorporated. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K162285. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBM iDO Viewer 1.2.1?

EBM iDO Viewer 1.2.1 is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is Ebm Technologies Incorporated. The 510(k) number is K162285.

When did EBM iDO Viewer 1.2.1 receive FDA 510(k) clearance?

EBM iDO Viewer 1.2.1 received FDA 510(k) clearance on 2017-01-27, under 510(k) number K162285.

Who is the listed applicant for EBM iDO Viewer 1.2.1?

The FDA 510(k) record lists Ebm Technologies Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBM iDO Viewer 1.2.1?

The FDA product code for EBM iDO Viewer 1.2.1 is LLZ.

Other records listing Ebm Technologies Incorporated as applicant

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.

K202292UDE

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Official Source

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