FDA 510(k) Application Details - K052328

Device Classification Name	Calculator, Pulmonary Function Data   More FDA Info for this Device
510(K) Number	K052328
Device Name	Calculator, Pulmonary Function Data
Applicant	ZAN MESSGERATE GMBH 908 MAIN STREET LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	JIM LEWIS Other 510(k) Applications for this Contact
Regulation Number	868.1880   More FDA Info for this Regulation Number
Classification Product Code	BZC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2005
Decision Date	12/22/2005
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