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FDA 510(k)

CLEARVIEW ENDOSCOPE COVER

K-Number: K080740 · 2008-12-31

ApplicantInvotec International, Inc.
Decision Date2008-12-31
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW ENDOSCOPE COVER is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 2008-12-31 under 510(k) number K080740. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARVIEW ENDOSCOPE COVER?

CLEARVIEW ENDOSCOPE COVER is a medical device that received FDA 510(k) clearance on 2008-12-31. The listed applicant is Invotec International, Inc.. The 510(k) number is K080740.

When did CLEARVIEW ENDOSCOPE COVER receive FDA 510(k) clearance?

CLEARVIEW ENDOSCOPE COVER received FDA 510(k) clearance on 2008-12-31, under 510(k) number K080740.

Who is the listed applicant for CLEARVIEW ENDOSCOPE COVER?

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

What is the FDA product code for CLEARVIEW ENDOSCOPE COVER?

The FDA product code for CLEARVIEW ENDOSCOPE COVER is EOB.

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Other records listing Invotec International, 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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