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510(k) K872793

DP-700 NIKMAN DEFIB-PADS by Nikomed U.S.A., Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
July 14, 1987
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 Nikomed U.S.A., Inc.

  • K022909 — NIKOMED TRACE 1 ECG ELECTRODES (January 9, 2003)
  • K000079 — NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M (February 4, 2000)
  • K950473 — DISPOSABLE ECG MONITORING ELECTRODE (December 12, 1995)
  • K950472 — DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM (November 14, 1995)
  • K950475 — DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 (November 14, 1995)
  • K950471 — DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM (November 6, 1995)
  • K950470 — DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM (November 6, 1995)
  • K950480 — DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM (November 6, 1995)
  • K950474 — DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM (November 6, 1995)
  • K950477 — DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM (November 6, 1995)

Other clearances for product code LDD

  • K203231 — Switched Internal Paddles (January 11, 2021)
  • 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)