510(k) K920948

TOPICAL SACRAL HYPERBARIC OXYGEN CHAMBER by Topox Therapeuutic Rentals, Inc. — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1992
Date Received
March 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type