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FDA 510(k)

CONFOSCAN 2 CONFOCAL MICROSCOPE

K-Number: K012416 · 2001-10-26

ApplicantNidek Technologies Srl
Decision Date2001-10-26
Product CodeHJO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CONFOSCAN 2 CONFOCAL MICROSCOPE 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 2001-10-26 under 510(k) number K012416. The device is classified under product code HJO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFOSCAN 2 CONFOCAL MICROSCOPE?

CONFOSCAN 2 CONFOCAL MICROSCOPE is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Nidek Technologies Srl. The 510(k) number is K012416.

When did CONFOSCAN 2 CONFOCAL MICROSCOPE receive FDA 510(k) clearance?

CONFOSCAN 2 CONFOCAL MICROSCOPE received FDA 510(k) clearance on 2001-10-26, under 510(k) number K012416.

Who is the listed applicant for CONFOSCAN 2 CONFOCAL MICROSCOPE?

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 CONFOSCAN 2 CONFOCAL MICROSCOPE?

The FDA product code for CONFOSCAN 2 CONFOCAL MICROSCOPE is HJO.

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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.

K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXK070231ORIONK061768MP-1 MICROPERIMETERK023719MP-1 MICRO PERIMETER

Related Devices (Code: HJO)

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.

K262637SLIT LAMP SL-D4 (Type: LED)Topcon CorporationK253834VISUREF 600Carl Zeiss Vision GmbHK231760HP-OCT (HP-OCT)Cylite Pty. , Ltd.K222372Kowa SL-19Kowa Company , Ltd.K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)K182306Sunkingdom Slit LampChongqing Sunkingdom Medical Instrument Co., Ltd.

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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