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510(k) K855015

NONINVASIVE TEMP. PACEMAKER NTP-1000 by Zmi Corp. — Product Code DRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
December 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by Zmi Corp.

  • K915100 — BRINDLEY & SMITH ET-1000 (September 14, 1992)
  • K915159 — PEDIATRIC MULTI-FUNCTION ELECTRODES (February 7, 1992)
  • K913484 — ZOLL D-900 DEFIBRILLATOR (December 16, 1991)
  • K911956 — ZOLL PD-1400 PACER/DEFIBRILLATOR (July 31, 1991)
  • K895032 — ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES (October 12, 1989)
  • K885166 — ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES (May 1, 1989)
  • K873402 — ZOLL NTP-1200 PACER/DEFIBRILLATOR (November 23, 1987)

Other clearances for product code DRO

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  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)