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FDA 510(k)

3nethra neo

K-Number: K183059 · 2018-12-21

Decision Date2018-12-21
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

3nethra neo is a medical device manufactured by Forus Health Pvt.Ltd. It received FDA 510(k) clearance on 2018-12-21 under approval number K183059. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3nethra neo?

3nethra neo is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Forus Health Pvt.Ltd. The 510(k) number is K183059.

When was 3nethra neo approved by the FDA?

3nethra neo received FDA 510(k) clearance on 2018-12-21, under approval number K183059.

What company makes 3nethra neo?

3nethra neo is manufactured by Forus Health Pvt.Ltd.

What is the FDA product code for 3nethra neo?

The FDA product code for 3nethra neo is HKI.

Other Devices by Forus Health Pvt.Ltd

Related Devices (Code: HKI)

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.