Cleared Traditional

MINI-PECG

K832883 · Intersect Systems, Inc. · Cardiovascular
Dec 1983
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K832883 is an FDA 510(k) clearance for the MINI-PECG, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Intersect Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1983, 102 days after receiving the submission on August 26, 1983. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K832883 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1983
Decision Date December 06, 1983
Days to Decision 102 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