Cleared Traditional

K964750 - EAGLE 4000 PATIENT MONITOR
(FDA 510(k) Clearance)

K964750 · Marquette Electronics, Inc. · Cardiovascular device

Feb 1997

Decision

87d

Days

—

Risk

K964750 is an FDA 510(k) clearance for the EAGLE 4000 PATIENT MONITOR..

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on February 21, 1997, 87 days after receiving the submission on November 26, 1996.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number	K964750 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 26, 1996
Decision Date	February 21, 1997
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF