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FDA 510(k)

AUTOMATIC OBJECTIVE REFRACTOR 2000

K-Number: K820877 · 1982-06-25

ApplicantDicon, Inc.
Decision Date1982-06-25
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC OBJECTIVE REFRACTOR 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Dicon, Inc.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K820877. 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 AUTOMATIC OBJECTIVE REFRACTOR 2000?

AUTOMATIC OBJECTIVE REFRACTOR 2000 is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Dicon, Inc.. The 510(k) number is K820877.

When did AUTOMATIC OBJECTIVE REFRACTOR 2000 receive FDA 510(k) clearance?

AUTOMATIC OBJECTIVE REFRACTOR 2000 received FDA 510(k) clearance on 1982-06-25, under 510(k) number K820877.

Who is the listed applicant for AUTOMATIC OBJECTIVE REFRACTOR 2000?

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

What is the FDA product code for AUTOMATIC OBJECTIVE REFRACTOR 2000?

The FDA product code for AUTOMATIC OBJECTIVE REFRACTOR 2000 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 Dicon, 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.

K822580AUTO PERIOMETER 3000K811347DICON AUTO PERIMETER 2000K811346DICON AUTO PERIMETER 200

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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