FDA 510(k) Application Details - K971947

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K971947
Device Name	Generator, Oxygen, Portable
Applicant	SIM ITALIA S.R.L. 55 NORTHERN BLVD., SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK 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	05/28/1997
Decision Date	10/03/1997
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