Cleared Traditional

K914969 - E350I ELECTROCARDIOGRAPH
(FDA 510(k) Clearance)

K914969 · Siemens Burdick, Inc. · Cardiovascular
Mar 1992
Decision
142d
Days
Risk

K914969 is an FDA 510(k) clearance for the E350I ELECTROCARDIOGRAPH..

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on March 26, 1992, 142 days after receiving the submission on November 5, 1991.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K914969 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1991
Decision Date March 26, 1992
Days to Decision 142 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOS
Device Class