FDA 510(k) Application Details - K051759

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K051759
Device Name	Chamber, Hyperbaric
Applicant	PERFORMANCE HYPERBARICS 2599 A OLINDA ROAD MAKAWAO, HI 96768 US Other 510(k) Applications for this Company
Contact	SPENCER FELDMAN 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	06/29/2005
Decision Date	11/17/2005
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