510(k) K945041

PARAGON PORTABLE by Pegabus Egerton, Ltd. — Product Code FNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1995
Date Received
October 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type