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510(k) K901593

IMEX DOP-TONE II by Imex Medical Systems, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1990
Date Received
April 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
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)
  • K944196 — IMWXDOP IR (May 12, 1995)
  • K942441 — IMEXDOP CT+ (August 23, 1994)
  • K910462 — POCKET DOP 3 (June 24, 1991)
  • K896613 — FLAT VASCULAR PROBE (February 16, 1990)
  • K882138 — IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER (November 7, 1988)

Other clearances for product code KNG

  • K252669 — Fetal Doppler U8-25, U9-25 (January 8, 2026)
  • K242846 — Doppler FHR Detector (BF-500D+, BF-560) (June 26, 2025)
  • K233823 — Ultrasonic Fetal Doppler (June 28, 2024)
  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K211940 — Fetal Doppler (January 7, 2022)
  • K212084 — Fetal Doppler (November 3, 2021)
  • K191110 — HeraBEAT™ US (November 14, 2019)
  • K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD- (May 29, 2019)
  • K182710 — Fetal Doppler, Model FD88 (March 1, 2019)