Cleared Traditional

CMS SYSTEM

K922528 · Micromedical Industries, Ltd. · Cardiovascular
May 1995
Decision
1079d
Days
Class 2
Risk

About This 510(k) Submission

K922528 is an FDA 510(k) clearance for the CMS SYSTEM, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Micromedical Industries, Ltd. (Northbrook, US). The FDA issued a Cleared decision on May 12, 1995, 1079 days after receiving the submission on May 28, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K922528 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1992
Decision Date May 12, 1995
Days to Decision 1079 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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