510(k) K992551

ALPHA INFUSION PUMP by Advanced Infusion, Inc. — Product Code MEB

K992551 is an FDA 510(k) premarket notification submitted by Advanced Infusion, Inc. for the device "ALPHA INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on October 27, 1999. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Advanced Infusion, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1999
Date Received
July 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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