Cleared Traditional

K914458 - ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
(FDA 510(k) Clearance)

K914458 · Medical Data Electronics · Cardiovascular

Dec 1991

Decision

63d

Days

Class 2

Risk

K914458 is an FDA 510(k) clearance for the ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD).

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on December 9, 1991, 63 days after receiving the submission on October 7, 1991.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number	K914458 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 1991
Decision Date	December 09, 1991
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement