PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)— 510(k) K983196

Clearance details

Applicant

Tz Medical, Inc.

Product code

Code DRO

Device class

Class 2

Regulation

21 CFR 870.5550

Advisory panel

Cardiovascular

Date received

1998-09-11

Decision date

1999-09-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lake Oswego, OR, US

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• K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 204132000-03-28
• K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT1999-09-15
• K974034 — PORTABLE INTENSIVE CARE UNIT1998-03-02

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• Z-1438-2013 — adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.Class II·Terminated·TZ Medical Inc.·20130430

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983196.