FDA 510(k) Application Details - K063476

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K063476
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	BREAS MEDICAL AB FORETAGSVAGEN 1 MOLNLYCKE 435 33 SE Other 510(k) Applications for this Company
Contact	KARL-JOHAN HOLM 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	11/16/2006
Decision Date	01/22/2007
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