FDA 510(k) Application Details - K081506

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K081506
Device Name	Chamber, Hyperbaric
Applicant	HYPERBARIC AMERICA, LLC 1811 COPPER RIDGE DR. SAN ANTONIO, TX 78259 US Other 510(k) Applications for this Company
Contact	TOM WORKMAN 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	05/29/2008
Decision Date	07/25/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review