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FDA 510(k)

INSTRUMENTS, OVERREFRACTION SYSTEM

K-Number: K782096 · 1979-01-26

ApplicantZeiss Humphrey System
Decision Date1979-01-26
Product CodeHLM
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INSTRUMENTS, OVERREFRACTION SYSTEM 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 1979-01-26 under 510(k) number K782096. The device is classified under product code HLM. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMENTS, OVERREFRACTION SYSTEM?

INSTRUMENTS, OVERREFRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 1979-01-26. The listed applicant is Zeiss Humphrey System. The 510(k) number is K782096.

When did INSTRUMENTS, OVERREFRACTION SYSTEM receive FDA 510(k) clearance?

INSTRUMENTS, OVERREFRACTION SYSTEM received FDA 510(k) clearance on 1979-01-26, under 510(k) number K782096.

Who is the listed applicant for INSTRUMENTS, OVERREFRACTION SYSTEM?

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 INSTRUMENTS, OVERREFRACTION SYSTEM?

The FDA product code for INSTRUMENTS, OVERREFRACTION SYSTEM is HLM.

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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 BIOMICROSCOPEK923348OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIEDK852639HUMPHREY FIELD ANALYZER MODEL 630K852638HUMPHREY IMAGE ANALYZER MODEL 110K821940THE HUMPHREY FIELD ANALYZER MODEL 610

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Related Devices (Code: HLM)

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.

K944022LENSCHEKLeica, Inc.K940997AL-3300Hoya Corp. USAK936199AUTOMATIC LENSOMETERCanon USA, Inc.K930441MARCO STANDARD LENSMETERS 101,201Marco Ophthalmic, Inc.K930445MARCO LM-770 DIGITAL PROJECTION LENSMETERMarco Ophthalmic, Inc.K924776BURTON LENSMETER - MODEL 2021R.H. Burton Co.

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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