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FDA 510(k)

PENTACAM SCHEIMPFLUG CAMERA

K-Number: K030719 · 2003-09-16

ApplicantOculus Optikgerate GmbH
Decision Date2003-09-16
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PENTACAM SCHEIMPFLUG CAMERA 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 2003-09-16 under 510(k) number K030719. 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 PENTACAM SCHEIMPFLUG CAMERA?

PENTACAM SCHEIMPFLUG CAMERA is a medical device that received FDA 510(k) clearance on 2003-09-16. The listed applicant is Oculus Optikgerate GmbH. The 510(k) number is K030719.

When did PENTACAM SCHEIMPFLUG CAMERA receive FDA 510(k) clearance?

PENTACAM SCHEIMPFLUG CAMERA received FDA 510(k) clearance on 2003-09-16, under 510(k) number K030719.

Who is the listed applicant for PENTACAM SCHEIMPFLUG CAMERA?

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 PENTACAM SCHEIMPFLUG CAMERA?

The FDA product code for PENTACAM SCHEIMPFLUG CAMERA is MXK.

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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 STK073508PARKONEK041841PACHYCAM

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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