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510(k) K850661

MATRIX DRI-IDEA BOOTIES by Matrix Medica, Inc.

K850661 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "MATRIX DRI-IDEA BOOTIES". The FDA issued a decision of Substantially Equivalent on March 11, 1985. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1985
Date Received
February 20, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)

FDA data resources