FDA 510(k) Application Details - K182956

Device Classification Name	Ventilator, Emergency, Powered (Resuscitator)   More FDA Info for this Device
510(K) Number	K182956
Device Name	Ventilator, Emergency, Powered (Resuscitator)
Applicant	International Biomedical 8206 Cross Park Drive Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	Amy Pieper Other 510(k) Applications for this Contact
Regulation Number	868.5925   More FDA Info for this Regulation Number
Classification Product Code	BTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2018
Decision Date	01/18/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review