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510(k) K915100

BRINDLEY & SMITH ET-1000 by Zmi Corp. — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1992
Date Received
November 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Zmi Corp.

  • 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)
  • K855015 — NONINVASIVE TEMP. PACEMAKER NTP-1000 (March 31, 1986)

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