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FDA 510(k)

KODAK MEDICAL X-RAY DEVELOPER & REPLEN.

K-Number: K801209 · 1980-06-26

ApplicantEastman Kodak Company
Decision Date1980-06-26
Product CodeIXW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK MEDICAL X-RAY DEVELOPER & REPLEN. is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1980-06-26 under 510(k) number K801209. The device is classified under product code IXW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK MEDICAL X-RAY DEVELOPER & REPLEN.?

KODAK MEDICAL X-RAY DEVELOPER & REPLEN. is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Eastman Kodak Company. The 510(k) number is K801209.

When did KODAK MEDICAL X-RAY DEVELOPER & REPLEN. receive FDA 510(k) clearance?

KODAK MEDICAL X-RAY DEVELOPER & REPLEN. received FDA 510(k) clearance on 1980-06-26, under 510(k) number K801209.

Who is the listed applicant for KODAK MEDICAL X-RAY DEVELOPER & REPLEN.?

The FDA 510(k) record lists Eastman Kodak Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODAK MEDICAL X-RAY DEVELOPER & REPLEN.?

The FDA product code for KODAK MEDICAL X-RAY DEVELOPER & REPLEN. is IXW.

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Other records listing Eastman Kodak Company 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.

K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

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Related Devices (Code: IXW)

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.

K111167XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINTVelopex International, Inc.K093503INTRAX FILM PROCESSORVelopex International, Inc.K091628OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAXProtec GmbH & Co. KGK024342RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000Daito Co., Ltd.K023801FILM PROCESSOR, MODEL LIFE RAY PRO 1000S.A.I.E.P. S.R.L.K023825FILM PROCESSOR, MODEL LIFE RAY PRO 2500S.A.I.E.P. S.R.L.

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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