Cleared Traditional

MINI PECG-MODIFICATION

K841148 · Intersect Systems, Inc. · Cardiovascular
Apr 1984
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K841148 is an FDA 510(k) clearance for the MINI PECG-MODIFICATION, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Intersect Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984, 27 days after receiving the submission on March 21, 1984. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K841148 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1984
Decision Date April 17, 1984
Days to Decision 27 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