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FDA 510(k)

PHOTOTHERAPY EYE PROTECTION FOR INFANTS

K-Number: K821765 · 1982-08-16

ApplicantRussell Terry Co.
Decision Date1982-08-16
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PHOTOTHERAPY EYE PROTECTION FOR INFANTS is the device name listed in this FDA 510(k) record. The listed applicant is Russell Terry Co.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K821765. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOTOTHERAPY EYE PROTECTION FOR INFANTS?

PHOTOTHERAPY EYE PROTECTION FOR INFANTS is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Russell Terry Co.. The 510(k) number is K821765.

When did PHOTOTHERAPY EYE PROTECTION FOR INFANTS receive FDA 510(k) clearance?

PHOTOTHERAPY EYE PROTECTION FOR INFANTS received FDA 510(k) clearance on 1982-08-16, under 510(k) number K821765.

Who is the listed applicant for PHOTOTHERAPY EYE PROTECTION FOR INFANTS?

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

What is the FDA product code for PHOTOTHERAPY EYE PROTECTION FOR INFANTS?

The FDA product code for PHOTOTHERAPY EYE PROTECTION FOR INFANTS is HOY.

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Related Devices (Code: HOY)

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.

K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEMOphthocare , Ltd.K971465NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSNational Healthcare Mfg. Corp.K944700ARCTIC PREMIER SERIESSungold Eyewear, Inc.K944857GOGGLE SAFEGUARDSellstrom Mfg. Co.K945351SHIELD, EYE, OPHTHALMICTaiwan Eva Industrial Co., Inc.K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)Universal Massage & Tanning, Inc.

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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