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510(k) K913484

ZOLL D-900 DEFIBRILLATOR by Zmi Corp. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1991
Date Received
August 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
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)
  • 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)
  • K855015 — NONINVASIVE TEMP. PACEMAKER NTP-1000 (March 31, 1986)

Other clearances for product code LDD

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  • K200849 — Tempus LS - Manual (July 24, 2020)
  • K182503 — Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators (June 3, 2019)
  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
  • K140502 — ZOLL E SERIES ALS (November 6, 2014)
  • K103651 — CARDIOMED (October 4, 2011)
  • K103783 — EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDI (June 16, 2011)
  • K103334 — CARDIO MED (January 18, 2011)
  • K103159 — CARDIO MED MODEL A102, H104, O101, P103, AND Z100 (January 11, 2011)
  • K102468 — ZOLL PROPAQ MD (September 30, 2010)