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FDA 510(k)

OBJECTIVE REFRACTOR

K-Number: K802029 · 1980-11-12

ApplicantZeiss Humphrey System
Decision Date1980-11-12
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OBJECTIVE REFRACTOR 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 1980-11-12 under 510(k) number K802029. The device is classified under product code HKO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBJECTIVE REFRACTOR?

OBJECTIVE REFRACTOR is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Zeiss Humphrey System. The 510(k) number is K802029.

When did OBJECTIVE REFRACTOR receive FDA 510(k) clearance?

OBJECTIVE REFRACTOR received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802029.

Who is the listed applicant for OBJECTIVE REFRACTOR?

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 OBJECTIVE REFRACTOR?

The FDA product code for OBJECTIVE REFRACTOR is HKO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 9 devices →

Related Devices (Code: HKO)

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.

K031831TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEMTopcon Medical Systems, Inc.K000327WAVESCAN WAVEFRONT SYSTEM MODEL HS 1Visx, IncorporatedK951179DIGITAL RETINOSCOPIC PHOTOMETERKudi Kalu, Inc.K945959VIDEO VISION ANALYZER (VIVA), VRB 100Tomey Corporation USAK942242AUTO REF-KERATOMETER, RK-3Cannon U.S.A., Inc.K940516AUTO REFF-30Canon, 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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