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510(k) K833751

PORTA PULSE III #D320 by Medical Research Laboratories, Inc. — Product Code LDD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1984
Date Received
October 26, 1983
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 Medical Research Laboratories, Inc.

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  • K012030 — PORTABLE INTENSIVE CARE UNIT (September 24, 2001)
  • K010207 — PORTABLE INSTENSIVE CARE UNIT (June 14, 2001)
  • K002232 — AEDEFIBRILLATOR (December 6, 2000)
  • K000712 — PORTABLE INTENSIVE CARE UNIT, MODEL PIC (April 27, 2000)
  • K983307 — MODIFICATION TO PORTABLE INTENSIVE CARE UNIT (November 20, 1998)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K952085 — DPD DEFIBRILLATOR (June 5, 1995)
  • K935922 — 360 SLX ADVISORY DEFIBRILLATOR (December 22, 1994)

Other clearances for product code LDD

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  • 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)