FDA 510(k)

KODAK XLS 8600 (PS)

K-Number: K951948 · 1995-09-13

ApplicantKodak Health Imaging Systems, Inc.

Decision Date1995-09-13

Product CodeLMC

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

KODAK XLS 8600 (PS) is the device name listed in this FDA 510(k) record. The listed applicant is Kodak Health Imaging Systems, Inc.. It received FDA 510(k) clearance on 1995-09-13 under 510(k) number K951948. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KODAK XLS 8600 (PS)?

KODAK XLS 8600 (PS) is a medical device that received FDA 510(k) clearance on 1995-09-13. The listed applicant is Kodak Health Imaging Systems, Inc.. The 510(k) number is K951948.

When did KODAK XLS 8600 (PS) receive FDA 510(k) clearance?

KODAK XLS 8600 (PS) received FDA 510(k) clearance on 1995-09-13, under 510(k) number K951948.

Who is the listed applicant for KODAK XLS 8600 (PS)?

The FDA 510(k) record lists Kodak Health Imaging Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KODAK XLS 8600 (PS)?

The FDA product code for KODAK XLS 8600 (PS) is LMC.

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Other records listing Kodak Health Imaging Systems, Inc. as applicant

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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.