FDA 510(k) Application Details - K123945

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K123945
Device Name	Meter, Peak Flow, Spirometry
Applicant	MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 PLATTSBURGH, NY 12901 US Other 510(k) Applications for this Company
Contact	CARI J REIL Other 510(k) Applications for this Contact
Regulation Number	868.1860   More FDA Info for this Regulation Number
Classification Product Code	BZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2012
Decision Date	04/17/2013
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