FDA 510(k) Application Details - K092991

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K092991
Device Name	Chamber, Hyperbaric
Applicant	ENVIRONMENTAL TECTONICS CORP. 125 JAMES WAY SOUTHAMPTON, PA 18966 US Other 510(k) Applications for this Company
Contact	GENE DAVIS Other 510(k) Applications for this Contact
Regulation Number	868.5470   More FDA Info for this Regulation Number
Classification Product Code	CBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2009
Decision Date	08/13/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review