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510(k) K921982

MATRX HOPE(R) 5 RESUSCITATOR by Matrix Medica, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1994
Date Received
April 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

Other clearances by Matrix Medica, Inc.

  • K961536 — FLEXSCOPE (September 18, 1996)
  • K923693 — KLORMAN (January 23, 1996)
  • 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)
  • 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)

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