FDA 510(k) Applications Submitted by Kelly Moeykens

FDA 510(k) Number Submission Date Device Name Applicant
K250094 01/14/2025 Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36 Neuralynx, Inc.
K200169 01/23/2020 VFS1 Bipolar Electrosurgical Generator FHC, Inc.
K231141 04/21/2023 STarFix Designer Software C0265 FHC, Inc.
K183123 11/13/2018 microTargeting Guideline 4000 5.0 System FHC, Inc.


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