FDA 510(k) Application Details - K223072

Device Classification Name	Esophagoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K223072
Device Name	Esophagoscope (Flexible Or Rigid)
Applicant	PENTAX of America, Inc. 3 Paragon Drive Montvale, NJ 07645-1782 US Other 510(k) Applications for this Company
Contact	William Goeller Other 510(k) Applications for this Contact
Regulation Number	874.4710   More FDA Info for this Regulation Number
Classification Product Code	EOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	12/02/2022
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