Cleared Traditional

PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT

K983232 · Tz Medical, Inc. · Cardiovascular
Sep 1999
Decision
366d
Days
Class 2
Risk

About This 510(k) Submission

K983232 is an FDA 510(k) clearance for the PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT, a Pacemaker, Cardiac, External Transcutaneous (non-invasive) (Class II — Special Controls, product code DRO), submitted by Tz Medical, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 15, 1999, 366 days after receiving the submission on September 14, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5550.

Submission Details

510(k) Number K983232 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1998
Decision Date September 15, 1999
Days to Decision 366 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRO — Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5550

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