Cleared Traditional

K883400 - OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE (FDA 510(k) Clearance)

K883400 · Abbott Laboratories · General Hospital
Dec 1989
Decision
476d
Days
Class 2
Risk

K883400 is an FDA 510(k) clearance for the OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE. This device is classified as a Container, I.v. (Class II - Special Controls, product code KPE).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 1, 1989, 476 days after receiving the submission on August 12, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5025.

Submission Details

510(k) Number K883400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1988
Decision Date December 01, 1989
Days to Decision 476 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code KPE — Container, I.v.
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5025