FDA 510(k) Applications Submitted by Queena Chen
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140579 |
03/06/2014 |
ULTRASONIC POCKET DOPPLER |
EDAN INSTRUMENTS, INC. |
| K160790 |
03/22/2016 |
Acclarix LX8 Diagnostic Ultrasound System |
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. |
| K213485 |
10/29/2021 |
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E |
Shenzhen AOJ Medical Technology Co., Ltd. |
| K213503 |
11/01/2021 |
Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E |
Shenzhen AOJ Medical Technology Co., Ltd. |
| K153475 |
12/02/2015 |
SD5 & SD6 Ultrasonic Tabletop Doppler |
EDAN INSTRUMENTS, INC. |
| K143695 |
12/24/2014 |
CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS INC |
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