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FDA 510(k)

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE

K-Number: K923211 · 1993-11-08

ApplicantZeiss Humphrey System
Decision Date1993-11-08
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Zeiss Humphrey System. It received FDA 510(k) clearance on 1993-11-08 under 510(k) number K923211. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE?

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE is a medical device that received FDA 510(k) clearance on 1993-11-08. The listed applicant is Zeiss Humphrey System. The 510(k) number is K923211.

When did DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE receive FDA 510(k) clearance?

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE received FDA 510(k) clearance on 1993-11-08, under 510(k) number K923211.

Who is the listed applicant for DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE?

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

What is the FDA product code for DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE?

The FDA product code for DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE is IYO.

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Other records listing Zeiss Humphrey System 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.

K942439ZEISS OPMILAS 144 SURGICAL LASERSK923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIEDK852639HUMPHREY FIELD ANALYZER MODEL 630K852638HUMPHREY IMAGE ANALYZER MODEL 110K821940THE HUMPHREY FIELD ANALYZER MODEL 610K802029OBJECTIVE REFRACTOR

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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