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FDA 510(k)

ResolutionMD

K-Number: K161130 · 2016-08-24

ApplicantCalgary Scientific, Inc.
Decision Date2016-08-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ResolutionMD is a medical device manufactured by Calgary Scientific, Inc.. It received FDA 510(k) clearance on 2016-08-24 under approval number K161130. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ResolutionMD?

ResolutionMD is a medical device that received FDA 510(k) clearance on 2016-08-24. It is manufactured by Calgary Scientific, Inc.. The 510(k) number is K161130.

When was ResolutionMD approved by the FDA?

ResolutionMD received FDA 510(k) clearance on 2016-08-24, under approval number K161130.

What company makes ResolutionMD?

ResolutionMD is manufactured by Calgary Scientific, Inc..

What is the FDA product code for ResolutionMD?

The FDA product code for ResolutionMD is LLZ.

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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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