Cleared Traditional

K915202 - INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH
(FDA 510(k) Clearance)

K915202 · Siemens Burdick, Inc. · Cardiovascular
May 1992
Decision
179d
Days
Risk

K915202 is an FDA 510(k) clearance for the INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH..

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on May 15, 1992, 179 days after receiving the submission on November 18, 1991.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number K915202 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1991
Decision Date May 15, 1992
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LOS
Device Class