STarFix Designer Software C0265— 510(k) K231141

Substantially Equivalent

FHC, Inc.

FDA 510(k) clearance K231141 for STarFix Designer Software C0265, Substantially Equivalent on 2023-09-08. Applicant: FHC, Inc.. Device class: 2.

Clearance details

Applicant: FHC, Inc.
Product code: Code QRI
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2023-04-21
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bowdoin, ME, US

Download summary PDF View on FDA.gov ↗

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