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510(k) K855015

Device
NONINVASIVE TEMP. PACEMAKER NTP-1000
Applicant
ZMI CORP.
510(k) number
K855015
Product code
DRO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-31
Date received
1985-12-16
Regulation
870.5550
Classification name
Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROLF S STUTZ
Address
325 Vassar St. Cambridge MA US 02139 02139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LP2001-10-12
K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.2001-10-12
K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data Electronics2000-03-28
K983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.1999-09-15
K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.1999-09-15
K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, Inc.1998-03-02
K962547CARDIOSERV PMarquette Electronics, Inc.1997-03-06
K963120RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEMMarquette Electronics, Inc.1997-02-28
K961138ESORT II + 400 SERIES MONITORMedical Data Electronics1996-12-10
K951593LIFEPAK 11Physio-Control Corp.1995-12-29
K950856ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000Zoll Medical Corp1995-12-29
K950483HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITORHewlett-Packard Co.1995-05-22
K926175K-DEFIB/PACE CARBON ELECTRODEKatecho, Inc.1993-04-15
K915757MODELS M1722A, M1723A, M1724A DEFIBRILLATORSHewlett-Packard Co.1992-07-30
K915328GEL-TACKatecho, Inc.1992-06-29

Legacy Summary#

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FDA Review#

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