FDA 510(k) Application Details - K123400

Device Classification Name	Spirometer, Therapeutic (Incentive)   More FDA Info for this Device
510(K) Number	K123400
Device Name	Spirometer, Therapeutic (Incentive)
Applicant	TRUDELL MEDICAL INTL. 725 THIRD ST. LONDON N5V 5G4 CA Other 510(k) Applications for this Company
Contact	DARRYL FISCHER Other 510(k) Applications for this Contact
Regulation Number	868.5690   More FDA Info for this Regulation Number
Classification Product Code	BWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2012
Decision Date	05/16/2013
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