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FDA 510(k)

AUTO REFRACTOMETER

K-Number: K831083 · 1983-06-10

ApplicantNidek, Inc.
Decision Date1983-06-10
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTO REFRACTOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 1983-06-10 under 510(k) number K831083. 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 AUTO REFRACTOMETER?

AUTO REFRACTOMETER is a medical device that received FDA 510(k) clearance on 1983-06-10. The listed applicant is Nidek, Inc.. The 510(k) number is K831083.

When did AUTO REFRACTOMETER receive FDA 510(k) clearance?

AUTO REFRACTOMETER received FDA 510(k) clearance on 1983-06-10, under 510(k) number K831083.

Who is the listed applicant for AUTO REFRACTOMETER?

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

What is the FDA product code for AUTO REFRACTOMETER?

The FDA product code for AUTO REFRACTOMETER is HKO.

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Other records listing Nidek, 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.

K050336OPD-STATION SOFTWAREK042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300K031733NON-CONTACT TONOMETER, MODEL NT-4000K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000K013694NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)K020876ECHOSCAN, MODEL US-1800

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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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