FDA 510(k) Applications Submitted by Edan Instruments, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180380 |
02/12/2018 |
vital signs monitor |
Edan Instruments, Inc. |
| K170995 |
04/03/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
| K171178 |
04/21/2017 |
Central Monitoring System |
Edan Instruments, Inc. |
| K171943 |
06/28/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
| K171942 |
06/28/2017 |
Electrocardiograph |
Edan Instruments, Inc. |
| K202336 |
08/17/2020 |
Patient Monitor |
Edan Instruments, Inc. |
| K192514 |
09/12/2019 |
Patient Monitor |
Edan Instruments, Inc. |
| K173003 |
09/27/2017 |
U50 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
| K202892 |
09/28/2020 |
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
Edan Instruments, Inc. |
| K131503 |
05/24/2013 |
SE-601 SERIES ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
| K131830 |
06/20/2013 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
EDAN INSTRUMENTS, INC. |
| K131971 |
06/28/2013 |
IM60/IM70 PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
| K142511 |
09/08/2014 |
U50 Diagnostic Ultrasound System |
EDAN INSTRUMENTS, INC. |
| K180408 |
02/14/2018 |
U60 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
| K161302 |
05/09/2016 |
PC ECG |
EDAN INSTRUMENTS, INC. |
| K100797 |
03/22/2010 |
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS |
EDAN INSTRUMENTS, INC. |
| K220308 |
02/02/2022 |
Patient Monitor: RespArray |
Edan Instruments, Inc. |
| K230184 |
01/23/2023 |
Holter ECG and ABP System |
Edan Instruments, Inc. |
| K092727 |
09/04/2009 |
H100B PULSE OXIMETER |
EDAN INSTRUMENTS, INC. |
| K102138 |
07/30/2010 |
ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER |
EDAN INSTRUMENTS, INC. |
| K190186 |
02/01/2019 |
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System |
Edan Instruments, Inc. |
| K222902 |
09/23/2022 |
Electrocardiograph: SE-1200 Pro and SE-1201 Pro |
Edan Instruments, Inc. |
| K140579 |
03/06/2014 |
ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
| K160876 |
03/30/2016 |
PC ECG |
EDAN INSTRUMENTS, INC. |
| K150901 |
04/03/2015 |
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express |
EDAN INSTRUMENTS, INC. |
| K160981 |
04/07/2016 |
Patient Monitor |
EDAN INSTRUMENTS, INC. |
| K161056 |
04/14/2016 |
Telemetry Transmitter |
Edan Instruments, Inc. |
| K150999 |
04/15/2015 |
Acclarix Diagnostic Ultrasound System |
EDAN INSTRUMENTS, INC. |
| K131818 |
06/20/2013 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
| K131819 |
06/20/2013 |
PC ECG |
EDAN INSTRUMENTS, INC. |
| K151787 |
07/01/2015 |
Holter System |
EDAN INSTRUMENTS, INC. |
| K151878 |
07/09/2015 |
Video Colposcope |
EDAN INSTRUMENTS, INC. |
| K152427 |
08/26/2015 |
PC ECG |
EDAN INSTRUMENTS, INC. |
| K152552 |
09/08/2015 |
Patient Monitor |
EDAN INSTRUMENTS, INC. |
| K153475 |
12/02/2015 |
SD5 & SD6 Ultrasonic Tabletop Doppler |
EDAN INSTRUMENTS, INC. |
| K110922 |
04/01/2011 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
| K110999 |
04/11/2011 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
EDAN INSTRUMENTS, INC. |
| K101539 |
06/03/2010 |
VITAL SIGNS MONITOR MODEL M3B |
EDAN INSTRUMENTS, INC. |
| K122574 |
08/23/2012 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 |
EDAN INSTRUMENTS, INC. |
| K123249 |
10/17/2012 |
DIAGNOSTIC ULTRASOUND SYSTEM |
EDAN INSTRUMENTS, INC. |
| K113623 |
12/05/2011 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
| K113653 |
12/12/2011 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
| K192791 |
09/30/2019 |
Diagnostic Ultrasound System |
Edan Instruments, Inc. |
| K151978 |
07/17/2015 |
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control |
EDAN INSTRUMENTS, INC. |
| K080087 |
01/11/2008 |
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR |
EDAN INSTRUMENTS, INC. |
| K100358 |
02/12/2010 |
CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS, INC. |
| K090367 |
02/13/2009 |
SE-601 SERIES ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
| K040480 |
02/25/2004 |
SONOTRAX ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
| K040903 |
04/07/2004 |
CADENCE, MODELS 2001 AND 2002 |
EDAN INSTRUMENTS, INC. |
| K091513 |
05/22/2009 |
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 |
EDAN INSTRUMENTS, INC. |
| K091680 |
06/10/2009 |
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
EDAN INSTRUMENTS, INC. |
| K092010 |
07/06/2009 |
PC ECG, MODEL SE-1010 |
EDAN INSTRUMENTS, INC. |
| K102140 |
07/29/2010 |
FETAL MONITORS, MODELS F2 AND F3 |
EDAN INSTRUMENTS, INC. |
| K082369 |
08/18/2008 |
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR |
EDAN INSTRUMENTS, INC. |
| K082602 |
09/08/2008 |
FETAL & MATERNAL MONITOR, MODEL F6, F9 |
EDAN INSTRUMENTS, INC. |
| K092997 |
09/28/2009 |
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 |
EDAN INSTRUMENTS, INC. |
| K102835 |
09/29/2010 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
| K073221 |
11/15/2007 |
CADENCE II |
EDAN INSTRUMENTS, INC. |
| K093869 |
12/17/2009 |
SE-601 SERIES ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
| K083821 |
12/22/2008 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
| K210139 |
01/19/2021 |
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 |
Edan Instruments, Inc. |
| K212278 |
07/20/2021 |
Electrocardiograph |
Edan Instruments, Inc. |
| K202856 |
09/28/2020 |
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, A |
Edan Instruments, Inc. |
| K101960 |
07/12/2010 |
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
| K102854 |
09/29/2010 |
PC ECG |
EDAN INSTRUMENTS, INC. |
| K102830 |
09/29/2010 |
ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
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