Cleared Traditional

PERSONAL DEFIBRILLATOR

K832833 · Physio-Control, Inc. · Cardiovascular
Oct 1984
Decision
434d
Days
Class 2
Risk

About This 510(k) Submission

K832833 is an FDA 510(k) clearance for the PERSONAL DEFIBRILLATOR, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on October 26, 1984, 434 days after receiving the submission on August 19, 1983. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number K832833 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1983
Decision Date October 26, 1984
Days to Decision 434 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code LDD — Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5300

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