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FDA 510(k)

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM

K-Number: K031831 · 2003-12-19

ApplicantTopcon Medical Systems, Inc.
Decision Date2003-12-19
Product CodeHKO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K031831. 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 TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM?

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Topcon Medical Systems, Inc.. The 510(k) number is K031831.

When did TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM receive FDA 510(k) clearance?

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM received FDA 510(k) clearance on 2003-12-19, under 510(k) number K031831.

Who is the listed applicant for TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM?

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

What is the FDA product code for TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM?

The FDA product code for TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM is HKO.

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Other records listing Topcon Medical Systems, 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.

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Related Devices (Code: HKO)

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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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