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FDA 510(k)

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)

K-Number: K042742 · 2004-10-13

ApplicantHeidelberg Engineering
Decision Date2004-10-13
Product CodeMXK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering. It received FDA 510(k) clearance on 2004-10-13 under 510(k) number K042742. 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 HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)?

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) is a medical device that received FDA 510(k) clearance on 2004-10-13. The listed applicant is Heidelberg Engineering. The 510(k) number is K042742.

When did HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) receive FDA 510(k) clearance?

HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) received FDA 510(k) clearance on 2004-10-13, under 510(k) number K042742.

Who is the listed applicant for HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)?

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

What is the FDA product code for HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)?

The FDA product code for HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) is MXK.

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Other records listing Heidelberg Engineering 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.

K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAK063191HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCTK052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)K943956RETINA TOMOGRAPH AND FLOWMETERK943955RETINA FLOWMETER

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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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