FDA 510(k) Application Details - K013123

Device Classification Name	Spirometer, Diagnostic   More FDA Info for this Device
510(K) Number	K013123
Device Name	Spirometer, Diagnostic
Applicant	ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. MCCORDSVILLE, IN 46055 US Other 510(k) Applications for this Company
Contact	PAUL DRYDEN 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	09/19/2001
Decision Date	03/14/2002
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