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FDA 510(k)

KODAK 1500 INTRAORAL CAMERA

K-Number: K091186 · 2009-08-18

ApplicantCarestream Health, Inc.
Decision Date2009-08-18
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KODAK 1500 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 2009-08-18 under 510(k) number K091186. 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 KODAK 1500 INTRAORAL CAMERA?

KODAK 1500 INTRAORAL CAMERA is a medical device that received FDA 510(k) clearance on 2009-08-18. The listed applicant is Carestream Health, Inc.. The 510(k) number is K091186.

When did KODAK 1500 INTRAORAL CAMERA receive FDA 510(k) clearance?

KODAK 1500 INTRAORAL CAMERA received FDA 510(k) clearance on 2009-08-18, under 510(k) number K091186.

Who is the listed applicant for KODAK 1500 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 KODAK 1500 INTRAORAL CAMERA?

The FDA product code for KODAK 1500 INTRAORAL CAMERA 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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