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510(k) K102138

ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER by Edan Instruments, Inc. — Product Code MAA

K102138 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER". The FDA issued a decision of Substantially Equivalent on October 28, 2010. The device falls under product code MAA (Monitor, Fetal Doppler Ultrasound), a Class II device regulated under 21 CFR 884.2660. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2010
Date Received
July 30, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Fetal Doppler Ultrasound
Device Class
Class II
Regulation Number
884.2660
Review Panel
RA
Submission Type

Other clearances by Edan Instruments, Inc.

  • K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (July 2, 2026)
  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
  • 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)

Other clearances for product code MAA

  • K090499 — LIFEDOP MODEL, L350R (March 31, 2009)
  • K915138 — GE SONOCHROME (October 20, 1992)
  • K905536 — FETAL DOPPLER (April 21, 1992)
  • K904600 — L582 TRANSDUCER (June 24, 1991)
  • K905456 — L328 TRANSDUCER (May 28, 1991)
  • K904951 — S5192R TRANSDUCER (April 29, 1991)
  • K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
  • K894992 — QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM (February 23, 1990)

FDA data resources