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FDA 510(k)

NONCON ROBO PACHY F&A

K-Number: K062763 · 2008-02-22

ApplicantKonan Medical, Inc.
Decision Date2008-02-22
Product CodeNQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NONCON ROBO PACHY F&A is the device name listed in this FDA 510(k) record. The listed applicant is Konan Medical, Inc.. It received FDA 510(k) clearance on 2008-02-22 under 510(k) number K062763. The device is classified under product code NQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NONCON ROBO PACHY F&A?

NONCON ROBO PACHY F&A is a medical device that received FDA 510(k) clearance on 2008-02-22. The listed applicant is Konan Medical, Inc.. The 510(k) number is K062763.

When did NONCON ROBO PACHY F&A receive FDA 510(k) clearance?

NONCON ROBO PACHY F&A received FDA 510(k) clearance on 2008-02-22, under 510(k) number K062763.

Who is the listed applicant for NONCON ROBO PACHY F&A?

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

What is the FDA product code for NONCON ROBO PACHY F&A?

The FDA product code for NONCON ROBO PACHY F&A is NQE.

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Other records listing Konan Medical, Inc. 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.

K203244CellChek 20 rcK191558Konan Specular Microscope XVIIK120264KONAN SPECULAR MICROSCOPE XIVK081797IMAGE STORAGE SYSTEM, MODEL KSS-400K040373KERATO ANALYZER (EKA)K950091KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000

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Related Devices (Code: NQE)

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.

K191558Konan Specular Microscope XVIIKonan Medical, Inc.K173980Specular Microscope CEM-530Nidek Co., Ltd.K171313EM-4000 Specular MicroscopeTomey CorporationK151706Specular Microscope CEM- 530Nidek Co., Ltd.K130565SPECULAR MICROSCOPE CEM-530Nidek Co., Ltd.K120264KONAN SPECULAR MICROSCOPE XIVKonan Medical, Inc.

Official Source

View on FDA Database →

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

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