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FDA 510(k)

PHOTO-THERAPY EYE PROTECTOR

K-Number: K840894 · 1984-03-23

ApplicantA & A Medical Supplies Co.
Decision Date1984-03-23
Product CodeFOK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHOTO-THERAPY EYE PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical Supplies Co.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840894. The device is classified under product code FOK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTO-THERAPY EYE PROTECTOR?

PHOTO-THERAPY EYE PROTECTOR is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is A & A Medical Supplies Co.. The 510(k) number is K840894.

When did PHOTO-THERAPY EYE PROTECTOR receive FDA 510(k) clearance?

PHOTO-THERAPY EYE PROTECTOR received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840894.

Who is the listed applicant for PHOTO-THERAPY EYE PROTECTOR?

The FDA 510(k) record lists A & A Medical Supplies Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHOTO-THERAPY EYE PROTECTOR?

The FDA product code for PHOTO-THERAPY EYE PROTECTOR is FOK.

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Related Devices (Code: FOK)

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.

K962290DEROYAL INDUSTRIES, INC. NEONATAL EYE COVERDebusk Technology Corp.K926118LIFE TRACE(R) BILIRUBIN MASKGraphic Controls Corp.K851918INFANT PHOTOTHERAPY MASKAlba Health CareK813214INFANT PHOTOTHERAPY MASKMontrose Phototherapy Supply

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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