FDA 510(k) Application Details - K190972

Device Classification Name	Nasopharyngoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K190972
Device Name	Nasopharyngoscope (Flexible Or Rigid)
Applicant	Ambu A/S Baltorpbakken 13 Ballerup 2750 DK Other 510(k) Applications for this Company
Contact	Gurpreet Kaur Rehal 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	04/15/2019
Decision Date	07/12/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review