FDA 510(k) Application Details - K981366

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K981366
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. YORBA LINDA, CA 92887-4645 US Other 510(k) Applications for this Company
Contact	LARRY MURDOCK Other 510(k) Applications for this Contact
Regulation Number	868.1890   More FDA Info for this Regulation Number
Classification Product Code	BTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/1998
Decision Date	10/30/1998
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