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 the device name listed in this FDA 510(k) record. The listed applicant is Synopsys (Northern Europe) , Ltd.. It received FDA 510(k) clearance on 2021-04-01 under 510(k) 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. The listed applicant is Synopsys (Northern Europe) , Ltd.. The 510(k) number is K203195.

When did Simpleware ScanIP Medical receive FDA 510(k) clearance?

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

Who is the listed applicant for Simpleware ScanIP Medical?

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

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.