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FDA 510(k)

KODAK EKTASIAN HG FILM (EHG-15)

K-Number: K970154 · 1997-04-04

ApplicantEastman Kodak Company
Decision Date1997-04-04
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KODAK EKTASIAN HG FILM (EHG-15) 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 1997-04-04 under 510(k) number K970154. 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 KODAK EKTASIAN HG FILM (EHG-15)?

KODAK EKTASIAN HG FILM (EHG-15) is a medical device that received FDA 510(k) clearance on 1997-04-04. The listed applicant is Eastman Kodak Company. The 510(k) number is K970154.

When did KODAK EKTASIAN HG FILM (EHG-15) receive FDA 510(k) clearance?

KODAK EKTASIAN HG FILM (EHG-15) received FDA 510(k) clearance on 1997-04-04, under 510(k) number K970154.

Who is the listed applicant for KODAK EKTASIAN HG FILM (EHG-15)?

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 EKTASIAN HG FILM (EHG-15)?

The FDA product code for KODAK EKTASIAN HG FILM (EHG-15) is IWZ.

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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: 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.

K954200VOXGRAMVoxelK9316043M 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 CompanyK862944KODAK CFT FILM SO-141Eastman 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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