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510(k) K911956

ZOLL PD-1400 PACER/DEFIBRILLATOR by Zmi Corp. — Product Code DRO

K911956 is an FDA 510(k) premarket notification submitted by Zmi Corp. for the device "ZOLL PD-1400 PACER/DEFIBRILLATOR". The FDA issued a decision of Substantially Equivalent on July 31, 1991. The device falls under product code DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)), a Class II device regulated under 21 CFR 870.5550. Zmi Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1991
Date Received
May 2, 1991
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)
  • 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)
  • K855015 — NONINVASIVE TEMP. PACEMAKER NTP-1000 (March 31, 1986)

Other clearances for product code DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (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)

FDA data resources