Cleared Abbreviated

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

K100129 · Ambu A/S · Cardiovascular
Jun 2010
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K100129 is an FDA 510(k) clearance for the AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X, a Electrode, Electrocardiograph (Class II — Special Controls, product code DRX), submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on June 11, 2010, 143 days after receiving the submission on January 19, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2360.

Submission Details

510(k) Number K100129 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2010
Decision Date June 11, 2010
Days to Decision 143 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRX — Electrode, Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2360

Similar Devices — DRX Electrode, Electrocardiograph

All 328
Physiotrace
K171244 · Nimbleheart, Inc. · Aug 2017
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
K140096 · Hmicro, Inc. · Jul 2014
BIOMODULE 3-M1
K123658 · Zephyr Technology Corporation · Apr 2013
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
K101576 · Team Innovations, Inc. · Jul 2010
IP-SET
K101685 · Integral Process Sas · Jul 2010
INTCO TAB ELECTRODE
K093327 · Shanghai Intco Electrode Manufacturing Co., Ltd. · May 2010

More from Ambu A/S

View all
Ambu? aScope? 5 Cysto HD (Standard Deflection); Ambu? aScope? 5 Cysto HD (Reverse Deflection)
K250269 · FAJ · Jun 2025
Ambu? aScope? 5 Cysto HD (Standard Deflection); Ambu? aScope? 5 Cysto HD (Reverse Deflection); Ambu? aBox? 2
K240849 · FAJ · Oct 2024
Ambu? aScope? 5 Cysto HD (Standard Deflection); Ambu? aScope? 5 Cysto HD (Reverse Deflection); Ambu? aView? 2 Advance
K240848 · FAJ · Oct 2024
Ambu? aScope? 5 Uretero (Standard Deflection); Ambu? aScope? 5 Uretero (Reverse Deflection); Ambu? aView? 2 Advance
K242108 · FGB · Aug 2024
Ambu? aScope? 5 Uretero (Standard Deflection); Ambu? aScope? 5 Uretero (Reverse Deflection); Ambu? aBox? 2
K233630 · FGB · Jun 2024