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510(k) K895032

ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES by Zmi Corp. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1989
Date Received
August 8, 1989
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)
  • K913484 — ZOLL D-900 DEFIBRILLATOR (December 16, 1991)
  • K911956 — ZOLL PD-1400 PACER/DEFIBRILLATOR (July 31, 1991)
  • 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)

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  • K150349 — Rapid Hair Removal Pads (July 14, 2015)
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  • 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)