Cleared Traditional

K900498 - MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
(FDA 510(k) Clearance)

K900498 · Cardiac Pacemakers, Inc. · General Hospital

Feb 1990

Decision

36d

Days

Class 2

Risk

K900498 is an FDA 510(k) clearance for the MODIFIED BETATRON IV INSULIN INFUSION SYSTEM, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Cardiac Pacemakers, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 23, 1990, 36 days after receiving the submission on January 18, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K900498 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 1990
Decision Date	February 23, 1990
Days to Decision	36 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—