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FDA 510(k)

PACHYCAM

K-Number: K041841 · 2005-01-28

ApplicantOculus Optikgerate GmbH
Decision Date2005-01-28
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PACHYCAM 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 2005-01-28 under 510(k) number K041841. 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 PACHYCAM?

PACHYCAM is a medical device that received FDA 510(k) clearance on 2005-01-28. The listed applicant is Oculus Optikgerate GmbH. The 510(k) number is K041841.

When did PACHYCAM receive FDA 510(k) clearance?

PACHYCAM received FDA 510(k) clearance on 2005-01-28, under 510(k) number K041841.

Who is the listed applicant for PACHYCAM?

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 PACHYCAM?

The FDA product code for PACHYCAM is MXK.

Related Clinical Trials

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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 STK073508PARKONEK030719PENTACAM 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

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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