510(k) K925449

REPLACEMENT RECHARGEABLE BATTERY PACK'S by Portable Power Systems, Inc. — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1993
Date Received
October 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type