Cleared Traditional

K915327 - ELITE II ELECTROCARDIOGRAPH,MODIFIED
(FDA 510(k) Clearance)

K915327 · Siemens Burdick, Inc. · Cardiovascular

Oct 1992

Decision

318d

Days

—

Risk

K915327 is an FDA 510(k) clearance for the ELITE II ELECTROCARDIOGRAPH,MODIFIED..

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on October 9, 1992, 318 days after receiving the submission on November 26, 1991.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number	K915327 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 1991
Decision Date	October 09, 1992
Days to Decision	318 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF