Cleared Traditional

K902254 - ESCORT MODEL 400T TELEMETRY ECG MONITOR
(FDA 510(k) Clearance)

K902254 · Medical Data Electronics · Cardiovascular

Jul 1990

Decision

67d

Days

Class 2

Risk

K902254 is an FDA 510(k) clearance for the ESCORT MODEL 400T TELEMETRY ECG MONITOR. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH).

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on July 27, 1990, 67 days after receiving the submission on May 21, 1990.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K902254 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1990
Decision Date	July 27, 1990
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—