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FDA 510(k)

OPHTHALMIC STAND

K-Number: K844363 · 1984-12-05

ApplicantLuneau Laboratories
Decision Date1984-12-05
Product CodeHMF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC STAND is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Laboratories. It received FDA 510(k) clearance on 1984-12-05 under 510(k) number K844363. The device is classified under product code HMF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC STAND?

OPHTHALMIC STAND is a medical device that received FDA 510(k) clearance on 1984-12-05. The listed applicant is Luneau Laboratories. The 510(k) number is K844363.

When did OPHTHALMIC STAND receive FDA 510(k) clearance?

OPHTHALMIC STAND received FDA 510(k) clearance on 1984-12-05, under 510(k) number K844363.

Who is the listed applicant for OPHTHALMIC STAND?

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

What is the FDA product code for OPHTHALMIC STAND?

The FDA product code for OPHTHALMIC STAND is HMF.

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.

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Other records listing Luneau Laboratories 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.

K850068LUNE AU CURETTESK844365COLOR VISION TESTERSK844364SKIASCOPIC RACKSK844362OPHTHALMIC CHAIR

Related Devices (Code: HMF)

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.

K935952ROTA SYSTEM 5000Rota Systems Medfurniture, Inc.K935945ROTA DATAMATE IRota Systems,Inc.K931839ROTA SYSTEM XLRota Systems Medfurniture, Inc.K930440MARCO INTERNATIONAL STANDMarco Ophthalmic, Inc.K924771BURTON OPHTHALMIC STAND - MODEL XL3200R.H. Burton Co.K924780BURTON OPHTHALMIC EXAM UNIT - MODEL 2201R.H. Burton Co.

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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