Cleared Traditional

K915658 - SPECTRA ECG (FDA 510(k) Clearance)

K915658 · Advanced Medical Products, Inc. · Cardiovascular device

Jun 1992

Decision

175d

Days

—

Risk

K915658 is an FDA 510(k) clearance for the SPECTRA ECG..

Submitted by Advanced Medical Products, Inc. (Liverpool, US). The FDA issued a Cleared decision on June 10, 1992, 175 days after receiving the submission on December 18, 1991.

This device falls under the Cardiovascular FDA review panel.

Submission Details

510(k) Number	K915658 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 18, 1991
Decision Date	June 10, 1992
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF