FDA 510(k) Application Details - K980878

Device Classification Name	Calculator, Pulmonary Function Interpretator (Diagnostic)   More FDA Info for this Device
510(K) Number	K980878
Device Name	Calculator, Pulmonary Function Interpretator (Diagnostic)
Applicant	KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. 9 EZEL STREET, PO BOX 389 TIRAT HACARMEL 39554 IL Other 510(k) Applications for this Company
Contact	CHARLES S IRVING Other 510(k) Applications for this Contact
Regulation Number	868.1900   More FDA Info for this Regulation Number
Classification Product Code	BZM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/09/1998
Decision Date	12/28/1998
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