SONOTRAX SERIES ULTRASONIC POCKET DOPPLER— 510(k) K101960

Name: FDA 510(k) clearance K101960
Creator: U.S. Food and Drug Administration
Published: 2010-08-10

Substantially Equivalent

Edan Instruments, Inc.

FDA 510(k) clearance K101960 for SONOTRAX SERIES ULTRASONIC POCKET DOPPLER, Substantially Equivalent on 2010-08-10. Applicant: Edan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Edan Instruments, Inc.
Product code: Code HEP
Device class: Class 2
Regulation: 21 CFR 884.2660
Advisory panel: Obstetrics/Gynecology
Date received: 2010-07-12
Decision date: 2010-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEP

view all

K023082 — BABYCARE2003-03-03
K920353 — ULTRACELL INSTRUMENT WIPE1992-09-15
K910462 — POCKET DOP 31991-06-24

More clearances from Edan Instruments, Inc.

view all

K251508 — Telemetry Monitor (iT30, iT50)2026-08-06
K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251591 — Holter ECG and ABP system (HolterABP)2026-02-09
K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)2025-12-23
K241882 — Fetal & Maternal Monitor (F15A, F15A Air)2025-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.