Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FOX EYE ALUMINUM SHIELD, OPHTHALMIC

K-Number: K940095 · 1994-03-01

ApplicantP.J. Products, Inc.
Decision Date1994-03-01
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

FOX EYE ALUMINUM SHIELD, OPHTHALMIC is the device name listed in this FDA 510(k) record. The listed applicant is P.J. Products, Inc.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K940095. 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 FOX EYE ALUMINUM SHIELD, OPHTHALMIC?

FOX EYE ALUMINUM SHIELD, OPHTHALMIC is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is P.J. Products, Inc.. The 510(k) number is K940095.

When did FOX EYE ALUMINUM SHIELD, OPHTHALMIC receive FDA 510(k) clearance?

FOX EYE ALUMINUM SHIELD, OPHTHALMIC received FDA 510(k) clearance on 1994-03-01, under 510(k) number K940095.

Who is the listed applicant for FOX EYE ALUMINUM SHIELD, OPHTHALMIC?

The FDA 510(k) record lists P.J. Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOX EYE ALUMINUM SHIELD, OPHTHALMIC?

The FDA product code for FOX EYE ALUMINUM SHIELD, OPHTHALMIC is HOY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing P.J. Products, 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.

K940213UNIVERSAL CUSHIONED METAL EYE SHIELDK940275UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD

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

View on FDA Database →

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

↑