K252066

inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)

510(k) number: K252066
Device name: inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)
Applicant: Vincent Healthcare Products Limited HK
Product code: BZE — Heater, Breathing System W/Wo Controller (Not Humidi
Decision date: 2026-06-18
Date received: 2025-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Anesthesiology

PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K252066.pdf

Official FDA record: K252066

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.