FDA 510(k) Application Details - K020974

Device Classification Name	Chamber, Hyperbaric   More FDA Info for this Device
510(K) Number	K020974
Device Name	Chamber, Hyperbaric
Applicant	ENVIRONMENTAL TECTONICS CORP. 125 JAMES WAY SOUTHAMPTON, PA 18966-3877 US Other 510(k) Applications for this Company
Contact	MICHAEL W ALLEN 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	03/26/2002
Decision Date	06/26/2002
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review