FDA 510(k) Application Details - K973128

Device Classification Name	Hood, Oxygen, Infant   More FDA Info for this Device
510(K) Number	K973128
Device Name	Hood, Oxygen, Infant
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	SUBHASH R PATEL Other 510(k) Applications for this Contact
Regulation Number	868.5700   More FDA Info for this Regulation Number
Classification Product Code	FOG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/1997
Decision Date	11/18/1997
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