Cleared Traditional

BETATRON IV SYSTEM

K872774 · Cardiac Pacemakers, Inc. · General Hospital
Jan 1988
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K872774 is an FDA 510(k) clearance for the BETATRON IV SYSTEM, 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 January 5, 1988, 175 days after receiving the submission on July 14, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K872774 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1987
Decision Date January 05, 1988
Days to Decision 175 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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