Cleared Traditional

K881986 - ESCORT - PORTABLE PATIENT MONITOR
(FDA 510(k) Clearance)

K881986 · Medical Data Electronics · Cardiovascular

Jul 1988

Decision

61d

Days

Class 2

Risk

K881986 is an FDA 510(k) clearance for the ESCORT - PORTABLE PATIENT 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 12, 1988, 61 days after receiving the submission on May 12, 1988.

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

Submission Details

510(k) Number	K881986 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 1988
Decision Date	July 12, 1988
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—