FDA 510(k) Application Details - K234096

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K234096
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	MedicalTek Co., Ltd. 4F., No.26 Keya Rd. Daya Dist. Taichung City 428 TW Other 510(k) Applications for this Company
Contact	Shen Ching (James) Yeh Other 510(k) Applications for this Contact
Regulation Number	874.4760   More FDA Info for this Regulation Number
Classification Product Code	EOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2023
Decision Date	09/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review