510(k) K895688

NOBLES-LAI ENGINEERING INFUSION PUMP by Nobles-Lai Engineering, Inc. — Product Code DQI

K895688 is an FDA 510(k) premarket notification submitted by Nobles-Lai Engineering, Inc. for the device "NOBLES-LAI ENGINEERING INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on February 26, 1990. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Nobles-Lai Engineering, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
September 22, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type