FDA 510(k) Application Details - K101380

Device Classification Name	Meter, Peak Flow, Spirometry   More FDA Info for this Device
510(K) Number	K101380
Device Name	Meter, Peak Flow, Spirometry
Applicant	NOBLE MARKETING 11460 N. MERIDIAN ST. SUITE 150 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	LAURA LYONS 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	05/17/2010
Decision Date	09/13/2010
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