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FDA 510(k)

CS 1600 INTRAORAL CAMERA

K-Number: K111423 · 2012-03-02

ApplicantCarestream Health, Inc.
Decision Date2012-03-02
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CS 1600 INTRAORAL CAMERA 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 2012-03-02 under 510(k) number K111423. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS 1600 INTRAORAL CAMERA?

CS 1600 INTRAORAL CAMERA is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Carestream Health, Inc.. The 510(k) number is K111423.

When did CS 1600 INTRAORAL CAMERA receive FDA 510(k) clearance?

CS 1600 INTRAORAL CAMERA received FDA 510(k) clearance on 2012-03-02, under 510(k) number K111423.

Who is the listed applicant for CS 1600 INTRAORAL CAMERA?

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 1600 INTRAORAL CAMERA?

The FDA product code for CS 1600 INTRAORAL CAMERA is NBL.

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Other records listing Carestream Health, Inc. as applicant

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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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