FDA 510(k) Application Details - K240430

Device Classification Name	Audiometer   More FDA Info for this Device
510(K) Number	K240430
Device Name	Audiometer
Applicant	Otodynamics Ltd 30-38 Beaconsfield Rd. Hatfield, Hertfordshire AL10-8BB GB Other 510(k) Applications for this Company
Contact	Daniel Budd Other 510(k) Applications for this Contact
Regulation Number	874.1050   More FDA Info for this Regulation Number
Classification Product Code	EWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2024
Decision Date	03/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review