FDA applicant
Neuro-Biometrix, Inc.
FDA records 2 decisions for Neuro-Biometrix, Inc. (Denver, CO) from 1997 to 1998: 2 510(k) clearances. All are in product code ETD (Tube, Tympanostomy). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neuro-Biometrix, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Neuro-Biometrix, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Neuro-Biometrix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Neuro-Biometrix”
FDA records each applicant name separately; these may or may not be the same firm.