Cleared Traditional

PUMP & DETECTOR

K813455 · Medlog GmbH Marketing Services · General Hospital
Jan 1982
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K813455 is an FDA 510(k) clearance for the PUMP & DETECTOR, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Medlog GmbH Marketing Services (Mchenry, US). The FDA issued a Cleared decision on January 5, 1982, 36 days after receiving the submission on November 30, 1981. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K813455 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1981
Decision Date January 05, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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