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FDA 510(k)

STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE

K-Number: K033123 · 2004-04-20

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2004-04-20
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2004-04-20 under 510(k) number K033123. 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 STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE?

STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE is a medical device that received FDA 510(k) clearance on 2004-04-20. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K033123.

When did STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE receive FDA 510(k) clearance?

STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE received FDA 510(k) clearance on 2004-04-20, under 510(k) number K033123.

Who is the listed applicant for STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE?

The FDA 510(k) record lists Carl Zeiss Meditec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE?

The FDA product code for STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE is HLI.

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Other records listing Carl Zeiss Meditec, Inc. as applicant

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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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