FDA 510(k) Application Details - K000995

Device Classification Name	Gas-Machine, Anesthesia   More FDA Info for this Device
510(K) Number	K000995
Device Name	Gas-Machine, Anesthesia
Applicant	HEYER AMERICA, INC. 3234 ELLA LN. NEW PORT RICHEY, FL 34655 US Other 510(k) Applications for this Company
Contact	ART WARD Other 510(k) Applications for this Contact
Regulation Number	868.5160   More FDA Info for this Regulation Number
Classification Product Code	BSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2000
Decision Date	10/11/2000
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