Cleared Traditional

NOBLES-LAI ENGINEERING INFUSION PUMP

K895688 · Nobles-Lai Engineering, Inc. · General Hospital
Feb 1990
Decision
157d
Days
Class 2
Risk

About This 510(k) Submission

K895688 is an FDA 510(k) clearance for the NOBLES-LAI ENGINEERING INFUSION PUMP, a Withdrawal/infusion Pump (Class II — Special Controls, product code DQI), submitted by Nobles-Lai Engineering, Inc. (Santa Ana, US). The FDA issued a Cleared decision on February 26, 1990, 157 days after receiving the submission on September 22, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1800.

Submission Details

510(k) Number K895688 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1989
Decision Date February 26, 1990
Days to Decision 157 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code DQI — Withdrawal/infusion Pump
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1800

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