Cleared Traditional

MONARK ERGOMETERS

K912227 · Quinton, Inc. · Physical Medicine
Aug 1991
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K912227 is an FDA 510(k) clearance for the MONARK ERGOMETERS, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on August 7, 1991, 83 days after receiving the submission on May 16, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K912227 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1991
Decision Date August 07, 1991
Days to Decision 83 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ISD — Exerciser, Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5360

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