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FDA 510(k)

EPLEY OMNIAX

K-Number: K071973 · 2008-06-20

ApplicantVesticon
Decision Date2008-06-20
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

EPLEY OMNIAX is the device name listed in this FDA 510(k) record. The listed applicant is Vesticon. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K071973. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPLEY OMNIAX?

EPLEY OMNIAX is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Vesticon. The 510(k) number is K071973.

When did EPLEY OMNIAX receive FDA 510(k) clearance?

EPLEY OMNIAX received FDA 510(k) clearance on 2008-06-20, under 510(k) number K071973.

Who is the listed applicant for EPLEY OMNIAX?

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

What is the FDA product code for EPLEY OMNIAX?

The FDA product code for EPLEY OMNIAX is LXV.

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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.

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