Cleared Traditional

INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123

K852060 · Cardiac Pacemakers, Inc. · General Hospital
Jun 1985
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K852060 is an FDA 510(k) clearance for the INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on June 7, 1985, 29 days after receiving the submission on May 9, 1985. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K852060 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1985
Decision Date June 07, 1985
Days to Decision 29 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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