FDA 510(k) Application Details - K092335

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K092335
Device Name	Meter, Peak Flow, Spirometry
Applicant	K-JUMP HEALTH CO., LTD. NO. 56, WU KUNG 5TH RD., WU KU INDUSTRIAL PARK TAIPEI HSIEN 248 TW Other 510(k) Applications for this Company
Contact	JASON CHENG 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	08/04/2009
Decision Date	04/09/2010
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