FDA 510(k) Application Details - K010613

Device Classification Name	Gas-Machine, Anesthesia   More FDA Info for this Device
510(K) Number	K010613
Device Name	Gas-Machine, Anesthesia
Applicant	OCEANIC MEDICAL PRODUCTS, INC. 8005 SHANNON INDUSTRIAL PARK LN. ATCHISON, KS 66002 US Other 510(k) Applications for this Company
Contact	WILLIAM M GATES 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	03/01/2001
Decision Date	10/12/2001
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