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FDA 510(k)

ANGIOSCAN (AS STAND ALONE INSTRUMENT)

K-Number: K951132 · 1995-06-26

ApplicantCarl Zeiss Meditec, Inc.
Decision Date1995-06-26
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ANGIOSCAN (AS STAND ALONE INSTRUMENT) 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 1995-06-26 under 510(k) number K951132. 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 ANGIOSCAN (AS STAND ALONE INSTRUMENT)?

ANGIOSCAN (AS STAND ALONE INSTRUMENT) is a medical device that received FDA 510(k) clearance on 1995-06-26. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K951132.

When did ANGIOSCAN (AS STAND ALONE INSTRUMENT) receive FDA 510(k) clearance?

ANGIOSCAN (AS STAND ALONE INSTRUMENT) received FDA 510(k) clearance on 1995-06-26, under 510(k) number K951132.

Who is the listed applicant for ANGIOSCAN (AS STAND ALONE INSTRUMENT)?

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 ANGIOSCAN (AS STAND ALONE INSTRUMENT)?

The FDA product code for ANGIOSCAN (AS STAND ALONE INSTRUMENT) is HLI.

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Other records listing Carl Zeiss Meditec, Inc. as applicant

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Related Devices (Code: HLI)

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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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