FDA 510(k)

3nethra neo HD FA; 3nethra neo HD

K-Number: K243600 · 2025-08-14

Decision Date2025-08-14

Product CodeHKI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

3nethra neo HD FA; 3nethra neo HD is a medical device manufactured by Forus Health Pvt.Ltd. It received FDA 510(k) clearance on 2025-08-14 under approval number K243600. 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 HD FA; 3nethra neo HD?

3nethra neo HD FA; 3nethra neo HD is a medical device that received FDA 510(k) clearance on 2025-08-14. It is manufactured by Forus Health Pvt.Ltd. The 510(k) number is K243600.

When was 3nethra neo HD FA; 3nethra neo HD approved by the FDA?

3nethra neo HD FA; 3nethra neo HD received FDA 510(k) clearance on 2025-08-14, under approval number K243600.

What company makes 3nethra neo HD FA; 3nethra neo HD?

3nethra neo HD FA; 3nethra neo HD is manufactured by Forus Health Pvt.Ltd.

What is the FDA product code for 3nethra neo HD FA; 3nethra neo HD?

The FDA product code for 3nethra neo HD FA; 3nethra neo HD is HKI.

Other Devices by Forus Health Pvt.Ltd

K1830593nethra neo

Related Devices (Code: HKI)

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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.