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510(k) K895525

MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER by Matrix Medica, Inc. — Product Code DRL

K895525 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER". The FDA issued a decision of Substantially Equivalent on January 26, 1990. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. 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 12, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Defibrillator
Device Class
Class II
Regulation Number
870.5325
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)
  • K895533 — LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER (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 DRL

  • K190437 — Delta 3300 (August 28, 2019)
  • K182905 — UniPulse (December 14, 2018)
  • K153210 — Defibrillator Analyzer Variable Load (December 21, 2015)
  • K110192 — DEFIBRILLATOR ANALYZER - DA-2006P (February 8, 2011)
  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)
  • K062099 — PHASE 3, MODEL DT-1 (January 25, 2007)
  • K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (July 11, 2003)
  • K963190 — QA-40M DEFIBRILLATOR TESTER (July 1, 1997)
  • K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000 (October 29, 1996)

FDA data resources