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FDA 510(k)

Eyer Retinal Camera NM-STD

K-Number: K221329 · 2023-02-22

ApplicantPhelcom Technologies
Decision Date2023-02-22
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Eyer Retinal Camera NM-STD is the device name listed in this FDA 510(k) record. The listed applicant is Phelcom Technologies. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221329. 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 Eyer Retinal Camera NM-STD?

Eyer Retinal Camera NM-STD is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Phelcom Technologies. The 510(k) number is K221329.

When did Eyer Retinal Camera NM-STD receive FDA 510(k) clearance?

Eyer Retinal Camera NM-STD received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221329.

Who is the listed applicant for Eyer Retinal Camera NM-STD?

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

What is the FDA product code for Eyer Retinal Camera NM-STD?

The FDA product code for Eyer Retinal Camera NM-STD is HKI.

Other records listing Phelcom Technologies 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.

K251353Eyer 2

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

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

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