FDA 510(k) Application Details - K043615

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K043615
Device Name	Generator, Oxygen, Portable
Applicant	OXYTEC MEDICAL CORPORATION 6329 W. WATERVIEW CT. MCCORDSVILLE, IN 46055-9501 US Other 510(k) Applications for this Company
Contact	PAUL E DRYDEN Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2004
Decision Date	02/09/2005
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