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FDA 510(k)

VISION TESTER

K-Number: K843042 · 1984-10-05

ApplicantStereo Optical Co., Inc.
Decision Date1984-10-05
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VISION TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Stereo Optical Co., Inc.. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K843042. 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 VISION TESTER?

VISION TESTER is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Stereo Optical Co., Inc.. The 510(k) number is K843042.

When did VISION TESTER receive FDA 510(k) clearance?

VISION TESTER received FDA 510(k) clearance on 1984-10-05, under 510(k) number K843042.

Who is the listed applicant for VISION TESTER?

The FDA 510(k) record lists Stereo Optical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISION TESTER?

The FDA product code for VISION TESTER 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 Stereo Optical Co., Inc. 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.

K924741OPTEC 3000K904828OPTEC 2300 AFVT, ARMED FORCES VISION TESTERK875237OPTEC 1000 DMV VISION TESTER MODIFYK863509OPTEC 1000 DMV

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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