FDA applicant
Bio Sig Instruments, Inc.
FDA records 3 decisions for Bio Sig Instruments, Inc. (Mchenry, IL) from 1978 to 1984: 3 510(k) clearances. Most are in product codes HCC (Device, Biofeedback) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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 Bio Sig Instruments, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bio Sig Instruments, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bio Sig Instruments, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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