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FDA 510(k)

NFC-600 Automated Portable Retinal Camera

K-Number: K210197 · 2021-04-13

ApplicantCrystalvue Medical Corporation
Decision Date2021-04-13
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NFC-600 Automated Portable Retinal Camera is the device name listed in this FDA 510(k) record. The listed applicant is Crystalvue Medical Corporation. It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K210197. 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 NFC-600 Automated Portable Retinal Camera?

NFC-600 Automated Portable Retinal Camera is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Crystalvue Medical Corporation. The 510(k) number is K210197.

When did NFC-600 Automated Portable Retinal Camera receive FDA 510(k) clearance?

NFC-600 Automated Portable Retinal Camera received FDA 510(k) clearance on 2021-04-13, under 510(k) number K210197.

Who is the listed applicant for NFC-600 Automated Portable Retinal Camera?

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

What is the FDA product code for NFC-600 Automated Portable Retinal Camera?

The FDA product code for NFC-600 Automated Portable Retinal Camera is HKI.

Other records listing Crystalvue Medical Corporation 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.

K182199NFC-700 non-mydriatic auto fundus cameraK180820Tono Vue Non-Contact Tonometer

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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