510(k) K001003

Z-NET by Demite Limited — Product Code FMW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2001
Date Received
March 29, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Mattress (Medical Purposes)
Device Class
Class I
Regulation Number
880.6190
Review Panel
HO
Submission Type