FDA 510(k) Application Details - K132172

Device Classification Name	Ventilator, Emergency, Manual (Resuscitator)   More FDA Info for this Device
510(K) Number	K132172
Device Name	Ventilator, Emergency, Manual (Resuscitator)
Applicant	LAERDAL MEDICAL A/S TANKE SVILANDSGT. 30 STAVANGER N-4000 NO Other 510(k) Applications for this Company
Contact	MARI KAADA Other 510(k) Applications for this Contact
Regulation Number	868.5915   More FDA Info for this Regulation Number
Classification Product Code	BTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/15/2013
Decision Date	01/15/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review