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510(k) K913320

MIL CM-II COAGULATION MACHINE by Medical Innovations Corp. — Product Code GKN

K913320 is an FDA 510(k) premarket notification submitted by Medical Innovations Corp. for the device "MIL CM-II COAGULATION MACHINE". The FDA issued a decision of Substantially Equivalent on June 16, 1992. The device falls under product code GKN (Timer, Clot, Automated), a Class II device regulated under 21 CFR 864.5400. Medical Innovations Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1992
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Timer, Clot, Automated
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Medical Innovations Corp.

  • K945612 — MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE (April 19, 1995)
  • K940548 — MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE (February 22, 1995)
  • K943685 — MIC DISPOSABLE SNARE (November 1, 1994)
  • K926581 — MIC TRANSGASTRIC JEJUNAL TUBE (September 28, 1994)
  • K921652 — MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT (May 2, 1994)
  • K921370 — MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION (May 2, 1994)
  • K924065 — MIC PEG TUBE (February 17, 1994)
  • K922667 — MIC LOW PROFILE GASTROSTOMY TUBE (December 1, 1993)
  • K903531 — ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (January 25, 1991)
  • K900464 — MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (December 5, 1990)

Other clearances for product code GKN

  • K953870 — ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS (October 31, 1995)
  • K940426 — MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (September 20, 1994)

FDA data resources