FDA 510(k) Application Details - K974372

Device Classification Name	Mixer, Breathing Gases, Anesthesia Inhalation   More FDA Info for this Device
510(K) Number	K974372
Device Name	Mixer, Breathing Gases, Anesthesia Inhalation
Applicant	SK MED 16000 SHERMAN WAY #224 VAN NUYS, CA 91406 US Other 510(k) Applications for this Company
Contact	DIPAK GHOSH Other 510(k) Applications for this Contact
Regulation Number	868.5330   More FDA Info for this Regulation Number
Classification Product Code	BZR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/1997
Decision Date	02/05/1998
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