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510(k) K973562

IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 by Imex Medical Systems, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1998
Date Received
September 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

Other clearances by Imex Medical Systems, Inc.

  • K973556 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 (April 24, 1998)
  • K973336 — IMEX STETHODOP (February 5, 1998)
  • K970156 — IMEX FUTURALDOP PRO (April 4, 1997)
  • K942243 — IMEX 8000 PERSONAL CASCULAR LAB (November 3, 1995)
  • K944196 — IMWXDOP IR (May 12, 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)

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