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FDA 510(k)

OPTISCAN MODEL OPTISCAN CEIS

K-Number: K093624 · 2010-03-05

ApplicantOptiscan Pty. , Ltd.
Decision Date2010-03-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPTISCAN MODEL OPTISCAN CEIS is the device name listed in this FDA 510(k) record. The listed applicant is Optiscan Pty. , Ltd.. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K093624. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTISCAN MODEL OPTISCAN CEIS?

OPTISCAN MODEL OPTISCAN CEIS is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Optiscan Pty. , Ltd.. The 510(k) number is K093624.

When did OPTISCAN MODEL OPTISCAN CEIS receive FDA 510(k) clearance?

OPTISCAN MODEL OPTISCAN CEIS received FDA 510(k) clearance on 2010-03-05, under 510(k) number K093624.

Who is the listed applicant for OPTISCAN MODEL OPTISCAN CEIS?

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

What is the FDA product code for OPTISCAN MODEL OPTISCAN CEIS?

The FDA product code for OPTISCAN MODEL OPTISCAN CEIS is GCJ.

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Related Devices (Code: GCJ)

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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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