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FDA 510(k)

ORWO X-RAY FILM

K-Number: K920539 · 1992-06-30

ApplicantBurkhart Roentgen Intl., Inc.
Decision Date1992-06-30
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORWO X-RAY FILM is the device name listed in this FDA 510(k) record. The listed applicant is Burkhart Roentgen Intl., Inc.. It received FDA 510(k) clearance on 1992-06-30 under 510(k) number K920539. 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 ORWO X-RAY FILM?

ORWO X-RAY FILM is a medical device that received FDA 510(k) clearance on 1992-06-30. The listed applicant is Burkhart Roentgen Intl., Inc.. The 510(k) number is K920539.

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

ORWO X-RAY FILM received FDA 510(k) clearance on 1992-06-30, under 510(k) number K920539.

Who is the listed applicant for ORWO X-RAY FILM?

The FDA 510(k) record lists Burkhart Roentgen Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Burkhart Roentgen Intl., 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.

K920538PROTECTIVE RADIOGRAFIC GLOVEK920540RADIOLOGICAL PROTECTIVE EYE SHIELD

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.K884827KODAK DENTAL BARRIER PACEastman Kodak CompanyK862944KODAK CFT FILM SO-141Eastman Kodak Company

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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