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FDA 510(k)

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)

K-Number: K951003 · 1995-04-03

ApplicantKenex , Ltd.
Decision Date1995-04-03
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) is the device name listed in this FDA 510(k) record. The listed applicant is Kenex , Ltd.. It received FDA 510(k) clearance on 1995-04-03 under 510(k) number K951003. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)?

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) is a medical device that received FDA 510(k) clearance on 1995-04-03. The listed applicant is Kenex , Ltd.. The 510(k) number is K951003.

When did KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) receive FDA 510(k) clearance?

KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) received FDA 510(k) clearance on 1995-04-03, under 510(k) number K951003.

Who is the listed applicant for KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)?

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

What is the FDA product code for KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)?

The FDA product code for KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) is KPY.

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 Kenex , Ltd. 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.

K951005KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)K951006KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)

Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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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