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FDA 510(k)

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED

K-Number: K923348 · 1992-12-10

ApplicantZeiss Humphrey System
Decision Date1992-12-10
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED 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 1992-12-10 under 510(k) number K923348. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED?

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED is a medical device that received FDA 510(k) clearance on 1992-12-10. The listed applicant is Zeiss Humphrey System. The 510(k) number is K923348.

When did OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED receive FDA 510(k) clearance?

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED received FDA 510(k) clearance on 1992-12-10, under 510(k) number K923348.

Who is the listed applicant for OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED?

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 OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED?

The FDA product code for OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED is ITX.

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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 LASERSK923211DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPEK852639HUMPHREY FIELD ANALYZER MODEL 630K852638HUMPHREY IMAGE ANALYZER MODEL 110K821940THE HUMPHREY FIELD ANALYZER MODEL 610K802029OBJECTIVE REFRACTOR

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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