Atlas FDA

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)

FDA 510(k) clearance K983196 · decided 1999-09-15

Clearance details

K-number
K983196
Device name
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
Applicant
Tz Medical, Inc.
Decision
Substantially Equivalent
Date received
1998-09-11
Decision date
1999-09-15
Days to decision
369 days
Clearance type
Traditional
Product code
DRO
Device class
2
Regulation number
870.5550
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lake Oswego, OR, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (K012218)The Ludlow Company LP2001-10-12
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (K012404)Katecho, Inc.2001-10-12
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 (K000660)Medical Data Electronics2000-03-28
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT (K983232)Tz Medical, Inc.1999-09-15
PORTABLE INTENSIVE CARE UNIT (K974034)Medical Research Laboratories, Inc.1998-03-02
CARDIOSERV P (K962547)Marquette Electronics, Inc.1997-03-06
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (K963120)Marquette Electronics, Inc.1997-02-28
ESORT II + 400 SERIES MONITOR (K961138)Medical Data Electronics1996-12-10
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000 (K950856)Zoll Medical Corp1995-12-29
LIFEPAK 11 (K951593)Physio-Control Corp.1995-12-29
HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR (K950483)Hewlett-Packard Co.1995-05-22
K-DEFIB/PACE CARBON ELECTRODE (K926175)Katecho, Inc.1993-04-15

Recalls involving this device

RecordFirmDate
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211 recall (Z-1438-2013)TZ Medical Inc.2013-05-30

PMA approvals by this applicant

RecordFirmDate
TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors (P200005)Tz Medical, Inc.2024-01-09