Cleared Traditional

K854234 - ESCORT ECG MONITOR SIEMENS SIRECUST 466
(FDA 510(k) Clearance)

K854234 · Medical Data Electronics · Cardiovascular

Jan 1986

Decision

92d

Days

Class 2

Risk

K854234 is an FDA 510(k) clearance for the ESCORT ECG MONITOR SIEMENS SIRECUST 466. This device is classified as a Electrocardiograph (Class II — Special Controls, product code DPS).

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on January 21, 1986, 92 days after receiving the submission on October 21, 1985.

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

Submission Details

510(k) Number	K854234 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 1985
Decision Date	January 21, 1986
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—