510(k) Report

FDA applicant

Cmc Sense-It, Inc.

Hopkins, MN4 decisions1996–19970 recalls

FDA records 4 decisions for Cmc Sense-It, Inc. (Hopkins, MN) from 1996 to 1997: 4 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and DSB (Plethysmograph, Impedance). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cmc Sense-It, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cmc Sense-It, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cmc Sense-It, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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