FDA 510(k) Application Details - K030418

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K030418
Device Name	Chamber, Hyperbaric
Applicant	MAKAI MARINE INDUSTRIES, INC. P.O. BOX 272039 BOCA RATON, FL 33427 US Other 510(k) Applications for this Company
Contact	MARC R KAISER 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	02/10/2003
Decision Date	01/29/2004
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