K232435

Rhinolaryngoscope system

510(k) number
K232435
Device name
Rhinolaryngoscope system
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd. CN
Product code
EOB — Nasopharyngoscope (Flexible Or Rigid)
Decision date
2024-04-26
Date received
2023-08-14
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K232435.pdf

Official FDA record: K232435
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.