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FDA 510(k)

MP-1 MICROPERIMETER

K-Number: K061768 · 2006-09-28

ApplicantNidek Technologies Srl
Decision Date2006-09-28
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MP-1 MICROPERIMETER 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 2006-09-28 under 510(k) number K061768. 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 MP-1 MICROPERIMETER?

MP-1 MICROPERIMETER is a medical device that received FDA 510(k) clearance on 2006-09-28. The listed applicant is Nidek Technologies Srl. The 510(k) number is K061768.

When did MP-1 MICROPERIMETER receive FDA 510(k) clearance?

MP-1 MICROPERIMETER received FDA 510(k) clearance on 2006-09-28, under 510(k) number K061768.

Who is the listed applicant for MP-1 MICROPERIMETER?

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 MP-1 MICROPERIMETER?

The FDA product code for MP-1 MICROPERIMETER is HKI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-EXK070231ORIONK023719MP-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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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