Cleared Traditional

K872291 - ESCORT PORTABLE PATIENT MONITOR
(FDA 510(k) Clearance)

Sep 1987
Decision
101d
Days
Class 2
Risk

K872291 is an FDA 510(k) clearance for the ESCORT PORTABLE PATIENT MONITOR. This device is classified as a Transducer, Pressure, Catheter Tip (Class II - Special Controls, product code DXO).

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on September 25, 1987, 101 days after receiving the submission on June 16, 1987.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2870.

Submission Details

510(k) Number K872291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1987
Decision Date September 25, 1987
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DXO — Transducer, Pressure, Catheter Tip
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2870