FDA 510(k) Application Details - K052158

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K052158
Device Name	Spirometer, Diagnostic
Applicant	WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS, NY 13153-0220 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER KLACZYK Other 510(k) Applications for this Contact
Regulation Number	868.1840   More FDA Info for this Regulation Number
Classification Product Code	BZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2005
Decision Date	09/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review