Cleared Traditional

K904355 - CARDIOCAP II TM CH-RESP MONITORS
(FDA 510(k) Clearance)

K904355 · Instrumentarium Corp. · Cardiovascular
May 1991
Decision
241d
Days
Class 2
Risk

K904355 is an FDA 510(k) clearance for the CARDIOCAP II TM CH-RESP MONITORS, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Instrumentarium Corp. (Finland, FI). The FDA issued a Cleared decision on May 23, 1991, 241 days after receiving the submission on September 24, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K904355 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1990
Decision Date May 23, 1991
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340