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510(k) K895533

LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER by Matrix Medica, Inc. — Product Code LDD

K895533 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER". The FDA issued a decision of Substantially Equivalent on January 26, 1990. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1990
Date Received
September 13, 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 Matrix Medica, Inc.

  • K961536 — FLEXSCOPE (September 18, 1996)
  • K923693 — KLORMAN (January 23, 1996)
  • K921982 — MATRX HOPE(R) 5 RESUSCITATOR (October 28, 1994)
  • K915353 — MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP (December 27, 1991)
  • K912661 — MATRX, PYRAMID TRIANGLE BANDAGE (August 21, 1991)
  • K900551 — MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC. (May 9, 1990)
  • K895525 — MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER (January 26, 1990)
  • K893219 — MATRX DENTAL UNIT (August 7, 1989)
  • K883833 — NITRONOX(R), FIRST RESPONSE NITRONOX(TM) (February 17, 1989)
  • K884879 — CENTURION(TM) MIXER (February 9, 1989)

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)

FDA data resources