FDA 510(k) Application Details - K993641

Device Classification Name	Calculator, Predicted Values, Pulmonary Function   More FDA Info for this Device
510(K) Number	K993641
Device Name	Calculator, Predicted Values, Pulmonary Function
Applicant	CORTEX BIOPHYSIK GMBH 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	ART WARD 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	10/28/1999
Decision Date	12/14/2000
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