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FDA 510(k)

Simpleware ScanIP Medical

K-Number: K203195 · 2021-04-01

ApplicantSynopsys (Northern Europe) , Ltd.
Decision Date2021-04-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Simpleware ScanIP Medical is a medical device manufactured by Synopsys (Northern Europe) , Ltd.. It received FDA 510(k) clearance on 2021-04-01 under approval number K203195. 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 Simpleware ScanIP Medical?

Simpleware ScanIP Medical is a medical device that received FDA 510(k) clearance on 2021-04-01. It is manufactured by Synopsys (Northern Europe) , Ltd.. The 510(k) number is K203195.

When was Simpleware ScanIP Medical approved by the FDA?

Simpleware ScanIP Medical received FDA 510(k) clearance on 2021-04-01, under approval number K203195.

What company makes Simpleware ScanIP Medical?

Simpleware ScanIP Medical is manufactured by Synopsys (Northern Europe) , Ltd..

What is the FDA product code for Simpleware ScanIP Medical?

The FDA product code for Simpleware ScanIP Medical is LLZ.

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Official Source

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