Cleared Traditional

K972199 - SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS
(FDA 510(k) Clearance)

K972199 · Marquette Electronics, Inc. · Cardiovascular

Sep 1997

Decision

106d

Days

Class 2

Risk

K972199 is an FDA 510(k) clearance for the SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS. This device is classified as a Electrocardiograph (Class II — Special Controls, product code DPS).

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 25, 1997, 106 days after receiving the submission on June 11, 1997.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K972199 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 1997
Decision Date	September 25, 1997
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF