510(k) K925449

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

K925449 is an FDA 510(k) premarket notification submitted by Portable Power Systems, Inc. for the device "REPLACEMENT RECHARGEABLE BATTERY PACK'S". The FDA issued a decision of Substantially Equivalent on April 29, 1993. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Portable Power Systems, Inc. has at least 10 other 510(k) clearances on record.

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