ECG Patient Isolation Amplifier PCA from Japan
This safety-critical printed circuit assembly provides galvanic isolation between patient electrodes and ECG processing electronics to prevent electrical shock. It qualifies for HTS 9018.11.60.00 as an essential accessory for electrocardiographs ensuring compliance with medical safety standards like IEC 60601. Includes optocouplers, transformers, and high-voltage barriers.
Duty Rate — Japan → United States
10%
Rate breakdown
9903.03.0110%Except for products described in headings 9903.03.02–9903.03.11, articles the product of any country, as provided for in subdivision (aa) of U.S. note 2 to this subchapter
Import Tips
• Submit IEC 60601-1 safety test reports and dielectric withstand certificates during customs entry
• Label assemblies clearly as 'ECG-specific isolation modules' to distinguish from industrial safety circuits
• Partner with FDA-registered importers to handle 510(k) predicate device linkage documentation