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FDA 510(k)

3nethra neo

K-Number: K183059 · 2018-12-21

ApplicantForus Health Pvt.Ltd
Decision Date2018-12-21
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

3nethra neo is the device name listed in this FDA 510(k) record. The listed applicant is Forus Health Pvt.Ltd. It received FDA 510(k) clearance on 2018-12-21 under 510(k) 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. The listed applicant is Forus Health Pvt.Ltd. The 510(k) number is K183059.

When did 3nethra neo receive FDA 510(k) clearance?

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

Who is the listed applicant for 3nethra neo?

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

What is the FDA product code for 3nethra neo?

The FDA product code for 3nethra neo is HKI.

Other records listing Forus Health Pvt.Ltd as applicant

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.

K2436003nethra neo HD FA; 3nethra neo HD

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

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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