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FDA 510(k)

Scope ProTech

K-Number: K191011 · 2019-05-07

ApplicantMeditech Endoscopy, Ltd.
Decision Date2019-05-07
Product CodeOCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Scope ProTech is a medical device manufactured by Meditech Endoscopy, Ltd.. It received FDA 510(k) clearance on 2019-05-07 under approval number K191011. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scope ProTech?

Scope ProTech is a medical device that received FDA 510(k) clearance on 2019-05-07. It is manufactured by Meditech Endoscopy, Ltd.. The 510(k) number is K191011.

When was Scope ProTech approved by the FDA?

Scope ProTech received FDA 510(k) clearance on 2019-05-07, under approval number K191011.

What company makes Scope ProTech?

Scope ProTech is manufactured by Meditech Endoscopy, Ltd..

What is the FDA product code for Scope ProTech?

The FDA product code for Scope ProTech is OCU.

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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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