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FDA 510(k)

NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX

K-Number: K113451 · 2012-05-08

ApplicantNidek Technologies Srl
Decision Date2012-05-08
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Technologies Srl. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K113451. 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 NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX?

NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Nidek Technologies Srl. The 510(k) number is K113451.

When did NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX receive FDA 510(k) clearance?

NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX received FDA 510(k) clearance on 2012-05-08, under 510(k) number K113451.

Who is the listed applicant for NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX?

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

What is the FDA product code for NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX?

The FDA product code for NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX is HKI.

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Other records listing Nidek Technologies Srl 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.

K070231ORIONK061768MP-1 MICROPERIMETERK023719MP-1 MICRO PERIMETERK012416CONFOSCAN 2 CONFOCAL MICROSCOPE

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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