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FDA 510(k)

RETINA TOMOGRAPH AND FLOWMETER

K-Number: K943956 · 1994-11-14

ApplicantHeidelberg Engineering
Decision Date1994-11-14
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RETINA TOMOGRAPH AND FLOWMETER is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering. It received FDA 510(k) clearance on 1994-11-14 under 510(k) number K943956. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RETINA TOMOGRAPH AND FLOWMETER?

RETINA TOMOGRAPH AND FLOWMETER is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is Heidelberg Engineering. The 510(k) number is K943956.

When did RETINA TOMOGRAPH AND FLOWMETER receive FDA 510(k) clearance?

RETINA TOMOGRAPH AND FLOWMETER received FDA 510(k) clearance on 1994-11-14, under 510(k) number K943956.

Who is the listed applicant for RETINA TOMOGRAPH AND FLOWMETER?

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 RETINA TOMOGRAPH AND FLOWMETER?

The FDA product code for RETINA TOMOGRAPH AND FLOWMETER is HLI.

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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)K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)K971671HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)K943955RETINA FLOWMETER

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Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

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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