FDA 510(k) Application Details - K171492

Device Classification Name	Bronchoscope (Flexible Or Rigid)   More FDA Info for this Device
510(K) Number	K171492
Device Name	Bronchoscope (Flexible Or Rigid)
Applicant	Spiration, Inc. 6675 185th Avenue N.E. Redmond, WA 98052 US Other 510(k) Applications for this Company
Contact	Cheryl Frederick Other 510(k) Applications for this Contact
Regulation Number	874.4680   More FDA Info for this Regulation Number
Classification Product Code	EOQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2017
Decision Date	11/20/2017
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