Cleared Traditional

CARDIOCAP MONITOR

K853953 · Instrumentarium Corp. · Cardiovascular
Jun 1986
Decision
250d
Days
Class 2
Risk

About This 510(k) Submission

K853953 is an FDA 510(k) clearance for the CARDIOCAP MONITOR, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Instrumentarium Corp. (Wilmington, US). The FDA issued a Cleared decision on June 2, 1986, 250 days after receiving the submission on September 25, 1985. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K853953 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1985
Decision Date June 02, 1986
Days to Decision 250 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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