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510(k) K915159

PEDIATRIC MULTI-FUNCTION ELECTRODES by Zmi Corp. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1992
Date Received
November 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Zmi Corp.

  • K915100 — BRINDLEY & SMITH ET-1000 (September 14, 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)
  • K855015 — NONINVASIVE TEMP. PACEMAKER NTP-1000 (March 31, 1986)

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