FDA 510(k) Application Details - K221206

Device Classification Name	Bronchoscope Accessory   More FDA Info for this Device
510(K) Number	K221206
Device Name	Bronchoscope Accessory
Applicant	Serpex Medical, Inc. 3350 Scott Blvd, Suite 37B Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Sasha Schrode Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	KTI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2022
Decision Date	08/25/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review