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510(k) K944196

IMWXDOP IR by Imex Medical Systems, Inc. — Product Code JAF

K944196 is an FDA 510(k) premarket notification submitted by Imex Medical Systems, Inc. for the device "IMWXDOP IR". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code JAF (Monitor, Ultrasonic, Nonfetal), a Class II device regulated under 21 CFR 892.1540. Imex Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1995
Date Received
August 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Nonfetal
Device Class
Class II
Regulation Number
892.1540
Review Panel
RA
Submission Type

Other clearances by Imex Medical Systems, Inc.

  • K973556 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 (April 24, 1998)
  • K973562 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 (April 15, 1998)
  • K973336 — IMEX STETHODOP (February 5, 1998)
  • K970156 — IMEX FUTURALDOP PRO (April 4, 1997)
  • K942243 — IMEX 8000 PERSONAL CASCULAR LAB (November 3, 1995)
  • K942441 — IMEXDOP CT+ (August 23, 1994)
  • K910462 — POCKET DOP 3 (June 24, 1991)
  • K901593 — IMEX DOP-TONE II (July 2, 1990)
  • K896613 — FLAT VASCULAR PROBE (February 16, 1990)
  • K882138 — IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER (November 7, 1988)

Other clearances for product code JAF

  • K242487 — Laminar P1 (LDH-HW-001) (December 13, 2024)
  • K141657 — THD REVOLUTION (February 24, 2015)
  • K110628 — SIMPLEABI (May 12, 2011)
  • K093393 — LIFEDOP MODEL 300ABI (December 24, 2009)
  • K090009 — THD SLIDE ONE (January 28, 2009)
  • K081429 — THD SLIDE (July 30, 2008)
  • K070815 — THD (June 20, 2007)
  • K063600 — VISTA AVS (December 19, 2006)
  • K060064 — STETHOFLUX (April 10, 2006)
  • K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H (August 29, 2005)

FDA data resources