FDA 510(k)

MEDINAUT Plus

K-Number: K182287 · 2019-04-06

Decision Date2019-04-06

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MEDINAUT Plus is a medical device manufactured by Imedicom Co., Ltd.. It received FDA 510(k) clearance on 2019-04-06 under approval number K182287. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDINAUT Plus?

MEDINAUT Plus is a medical device that received FDA 510(k) clearance on 2019-04-06. It is manufactured by Imedicom Co., Ltd.. The 510(k) number is K182287.

When was MEDINAUT Plus approved by the FDA?

MEDINAUT Plus received FDA 510(k) clearance on 2019-04-06, under approval number K182287.

What company makes MEDINAUT Plus?

MEDINAUT Plus is manufactured by Imedicom Co., Ltd..

What is the FDA product code for MEDINAUT Plus?

The FDA product code for MEDINAUT Plus is HRX.

Other Devices by Imedicom Co., Ltd.

K153296MEDINAUT Kyphoplasty System K150915SPINAUT-P K151268SPINAUT-V, SPINAUT-S, SPINAUT-I K150789SPINAUT-E, SPINAUT-I K173541EPINAUT

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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.