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FDA 510(k)

FR MEDICAL X-RAY FILM

K-Number: K840806 · 1984-04-24

ApplicantFr Medical/Fr Chemicals
Decision Date1984-04-24
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FR MEDICAL X-RAY FILM is the device name listed in this FDA 510(k) record. The listed applicant is Fr Medical/Fr Chemicals. It received FDA 510(k) clearance on 1984-04-24 under 510(k) number K840806. 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 FR MEDICAL X-RAY FILM?

FR MEDICAL X-RAY FILM is a medical device that received FDA 510(k) clearance on 1984-04-24. The listed applicant is Fr Medical/Fr Chemicals. The 510(k) number is K840806.

When did FR MEDICAL X-RAY FILM receive FDA 510(k) clearance?

FR MEDICAL X-RAY FILM received FDA 510(k) clearance on 1984-04-24, under 510(k) number K840806.

Who is the listed applicant for FR MEDICAL X-RAY FILM?

The FDA 510(k) record lists Fr Medical/Fr Chemicals as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FR MEDICAL X-RAY FILM?

The FDA product code for FR MEDICAL X-RAY FILM is IWZ.

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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.

K970154KODAK EKTASIAN HG FILM (EHG-15)Eastman Kodak CompanyK954200VOXGRAMVoxelK9316043M MEDICAL DIAGNOSTIC VIDEOCASSETTE3M Health Care, Ltd.K9316053M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE3M Health Care, Ltd.K920539ORWO X-RAY FILMBurkhart Roentgen Intl., Inc.K884827KODAK DENTAL BARRIER PACEastman Kodak Company

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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