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FDA 510(k)

CS 1200

K-Number: K112321 · 2011-11-10

ApplicantCarestream Health, Inc.
Decision Date2011-11-10
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CS 1200 is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2011-11-10 under 510(k) number K112321. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS 1200?

CS 1200 is a medical device that received FDA 510(k) clearance on 2011-11-10. The listed applicant is Carestream Health, Inc.. The 510(k) number is K112321.

When did CS 1200 receive FDA 510(k) clearance?

CS 1200 received FDA 510(k) clearance on 2011-11-10, under 510(k) number K112321.

Who is the listed applicant for CS 1200?

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

What is the FDA product code for CS 1200?

The FDA product code for CS 1200 is EIA.

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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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