FDA 510(k) Application Details - K130828

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K130828
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	CURATIVE MEDICAL INC. 6518 TAMARIND SKY LN. FULSHEAR, TX 77441 US Other 510(k) Applications for this Company
Contact	AMY MCKINNEY Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/26/2013
Decision Date	01/13/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review