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510(k) K101960

SONOTRAX SERIES ULTRASONIC POCKET DOPPLER by Edan Instruments, Inc. — Product Code HEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2010
Date Received
July 12, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Flow, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Edan Instruments, Inc.

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  • K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) (December 23, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K250214 — Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix (February 20, 2025)
  • K240320 — Patient Monitor (RespArray) (June 28, 2024)
  • K232786 — Stimulation System (PA series, PR series, S series and Q series) (May 16, 2024)
  • K232962 — Patient Monitor (iX10, iX12, iX15) (April 19, 2024)
  • K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s (March 8, 2024)
  • K232694 — Central Monitoring System (MFM-CMS) (February 5, 2024)

Other clearances for product code HEP

  • K023082 — BABYCARE (March 3, 2003)
  • K920353 — ULTRACELL INSTRUMENT WIPE (September 15, 1992)
  • K910462 — POCKET DOP 3 (June 24, 1991)