FDA 510(k) Application Details - K102047

Device Classification Name	Calculator, Pulmonary Function Data   More FDA Info for this Device
510(K) Number	K102047
Device Name	Calculator, Pulmonary Function Data
Applicant	INNOVISION A/S 10 E. SCRANTON AVE., SUITE 201 LAKE BLUFF, IL 60044 US Other 510(k) Applications for this Company
Contact	H. CARL JENKINS 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	07/21/2010
Decision Date	11/01/2011
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