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FDA 510(k)

OPTUM, INTRAORAL CAMERA SYSTEM

K-Number: K983739 · 1999-01-19

ApplicantCamsight, Inc.
Decision Date1999-01-19
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTUM, INTRAORAL CAMERA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Camsight, Inc.. It received FDA 510(k) clearance on 1999-01-19 under 510(k) number K983739. 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 OPTUM, INTRAORAL CAMERA SYSTEM?

OPTUM, INTRAORAL CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-19. The listed applicant is Camsight, Inc.. The 510(k) number is K983739.

When did OPTUM, INTRAORAL CAMERA SYSTEM receive FDA 510(k) clearance?

OPTUM, INTRAORAL CAMERA SYSTEM received FDA 510(k) clearance on 1999-01-19, under 510(k) number K983739.

Who is the listed applicant for OPTUM, INTRAORAL CAMERA SYSTEM?

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

What is the FDA product code for OPTUM, INTRAORAL CAMERA SYSTEM?

The FDA product code for OPTUM, INTRAORAL CAMERA SYSTEM is EIA.

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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.

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