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FDA 510(k)

IN-HOME VISION MONITORING KIT

K-Number: K854047 · 1985-12-13

Decision Date1985-12-13
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IN-HOME VISION MONITORING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rich-Larky Company, Inc.. It received FDA 510(k) clearance on 1985-12-13 under 510(k) number K854047. The device is classified under product code HOX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN-HOME VISION MONITORING KIT?

IN-HOME VISION MONITORING KIT is a medical device that received FDA 510(k) clearance on 1985-12-13. The listed applicant is Rich-Larky Company, Inc.. The 510(k) number is K854047.

When did IN-HOME VISION MONITORING KIT receive FDA 510(k) clearance?

IN-HOME VISION MONITORING KIT received FDA 510(k) clearance on 1985-12-13, under 510(k) number K854047.

Who is the listed applicant for IN-HOME VISION MONITORING KIT?

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

What is the FDA product code for IN-HOME VISION MONITORING KIT?

The FDA product code for IN-HOME VISION MONITORING KIT is HOX.

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.

Related Devices (Code: HOX)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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