510(k) K040145

ATA HCM MONOPLACE HYPERBARIC SYSTEM by Ata Hyperbaric Chamber Manufacturing — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2005
Date Received
January 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type