Cleared Traditional

K840167 - PORTABLE DEFIBRILLATOR
(FDA 510(k) Clearance)

K840167 · Honeywell, Inc. · Cardiovascular

Feb 1984

Decision

19d

Days

Class 2

Risk

K840167 is an FDA 510(k) clearance for the PORTABLE DEFIBRILLATOR. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD).

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 19 days after receiving the submission on January 16, 1984.

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

Submission Details

510(k) Number	K840167 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1984
Decision Date	February 04, 1984
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—