510(k) K974868

SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER by Perry Baromedical Corp. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1998
Date Received
December 29, 1997
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