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FDA 510(k)

WILCOR-XR RP MEDICAL FILM

K-Number: K834613 · 1984-03-05

Decision Date1984-03-05
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WILCOR-XR RP MEDICAL FILM is the device name listed in this FDA 510(k) record. The listed applicant is Cea America Corp.. It received FDA 510(k) clearance on 1984-03-05 under 510(k) number K834613. The device is classified under product code IWZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILCOR-XR RP MEDICAL FILM?

WILCOR-XR RP MEDICAL FILM is a medical device that received FDA 510(k) clearance on 1984-03-05. The listed applicant is Cea America Corp.. The 510(k) number is K834613.

When did WILCOR-XR RP MEDICAL FILM receive FDA 510(k) clearance?

WILCOR-XR RP MEDICAL FILM received FDA 510(k) clearance on 1984-03-05, under 510(k) number K834613.

Who is the listed applicant for WILCOR-XR RP MEDICAL FILM?

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

What is the FDA product code for WILCOR-XR RP MEDICAL FILM?

The FDA product code for WILCOR-XR RP MEDICAL FILM is IWZ.

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.

Other records listing Cea America Corp. 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.

Related Devices (Code: IWZ)

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.

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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