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FDA 510(k)

PARKONE

K-Number: K073508 · 2008-09-11

ApplicantOculus Optikgerate GmbH
Decision Date2008-09-11
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PARKONE is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Optikgerate GmbH. It received FDA 510(k) clearance on 2008-09-11 under 510(k) number K073508. The device is classified under product code MXK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARKONE?

PARKONE is a medical device that received FDA 510(k) clearance on 2008-09-11. The listed applicant is Oculus Optikgerate GmbH. The 510(k) number is K073508.

When did PARKONE receive FDA 510(k) clearance?

PARKONE received FDA 510(k) clearance on 2008-09-11, under 510(k) number K073508.

Who is the listed applicant for PARKONE?

The FDA 510(k) record lists Oculus Optikgerate GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARKONE?

The FDA product code for PARKONE is MXK.

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.

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Other records listing Oculus Optikgerate GmbH 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.

K201724Pentacam AXL WaveK152311Pentacam AXLK113066CORVIS STK041841PACHYCAMK030719PENTACAM SCHEIMPFLUG CAMERA

Related Devices (Code: MXK)

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.

K251848Pentacam® Cornea OCTOculus Optikgeräte GmbHK252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey CorporationK223700BOSS™Intelon Optics, Inc.K222933MYAHVisia Imaging S.R.L.K211868MYAHVisia Imaging S.R.L.K202989Myopia MasterOculus Optikgeräte GmbH

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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