Cleared Traditional

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB

K904556 · Boston Scientific Corp · Physical Medicine
Dec 1991
Decision
439d
Days
Class 1
Risk

About This 510(k) Submission

K904556 is an FDA 510(k) clearance for the MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB, a Treadmill, Powered (Class I — General Controls, product code IOL), submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 18, 1991, 439 days after receiving the submission on October 5, 1990. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K904556 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 1990
Decision Date December 18, 1991
Days to Decision 439 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOL — Treadmill, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380

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