510(k) K052713

MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER by Sechrist Industries, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2005
Date Received
September 29, 2005
Clearance Type
Special
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