FDA 510(k)

STarFix Designer Software C0265

K-Number: K231141 · 2023-09-08

Decision Date2023-09-08

Product CodeQRI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

STarFix Designer Software C0265 is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231141. The device is classified under product code QRI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STarFix Designer Software C0265?

STarFix Designer Software C0265 is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is FHC, Inc.. The 510(k) number is K231141.

When did STarFix Designer Software C0265 receive FDA 510(k) clearance?

STarFix Designer Software C0265 received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231141.

Who is the listed applicant for STarFix Designer Software C0265?

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

What is the FDA product code for STarFix Designer Software C0265?

The FDA product code for STarFix Designer Software C0265 is QRI.

Other records listing FHC, Inc. as applicant

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Official Source

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