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510(k) K962615

TUMORLOCALIZER MRI by Ferguson Medical — Product Code MIG

K962615 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "TUMORLOCALIZER MRI". The FDA issued a decision of Substantially Equivalent on March 19, 1998. The device falls under product code MIG (Strip, Test Isoniazid), a Class U device. Ferguson Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1998
Date Received
July 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Test Isoniazid
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Ferguson Medical

  • K033153 — DICOM THEATER (April 23, 2004)
  • K963794 — PUNCTURENEEDLE (March 19, 1998)
  • K971813 — EMBLA (January 16, 1998)
  • K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
  • K972217 — ORTHOPEDIC SCREW SYSTEM (November 20, 1997)
  • K970819 — TARGOBEAM (July 14, 1997)
  • K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTE (May 22, 1997)
  • K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)
  • K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMOR (May 22, 1997)
  • K960421 — SINUSCAN 102/SINUSPRINT (April 16, 1997)

Other clearances for product code MIG

  • K912888 — URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL (February 24, 1992)

FDA data resources