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FDA 510(k)

KODAKEKTACHEM DTR MODULE

K-Number: K854138 · 1985-11-12

ApplicantEastman Kodak Company
Decision Date1985-11-12
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KODAKEKTACHEM DTR MODULE 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 1985-11-12 under 510(k) number K854138. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAKEKTACHEM DTR MODULE?

KODAKEKTACHEM DTR MODULE is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Eastman Kodak Company. The 510(k) number is K854138.

When did KODAKEKTACHEM DTR MODULE receive FDA 510(k) clearance?

KODAKEKTACHEM DTR MODULE received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854138.

Who is the listed applicant for KODAKEKTACHEM DTR MODULE?

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 KODAKEKTACHEM DTR MODULE?

The FDA product code for KODAKEKTACHEM DTR MODULE is JJE.

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Other records listing Eastman Kodak Company as applicant

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Related Devices (Code: JJE)

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.

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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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