FDA 510(k) 实质等同认定·· 2026-08-12
510(k) 实质等同认定：Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe) (SPA-C02); Disposable Sterile Steep Pulse Probe (NPA-DJ01); Probe connection line (NPA-LX-02)（K253846）
来源：FDA 510(k) 实质等同认定 · accessdata.fda.gov