FDA 510(k)

L- OVC

K-Number: K162677 · 2016-12-21

Decision Date2016-12-21

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

L- OVC is the device name listed in this FDA 510(k) record. The listed applicant is Rhondium, Ltd.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162677. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L- OVC?

L- OVC is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Rhondium, Ltd.. The 510(k) number is K162677.

When did L- OVC receive FDA 510(k) clearance?

L- OVC received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162677.

Who is the listed applicant for L- OVC?

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

What is the FDA product code for L- OVC?

The FDA product code for L- OVC is EIH.

Related Devices (Code: EIH)

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.

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Official Source

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