|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
electrocardiograph: se-1200 pro and se-1201 pro
|
Edan Instruments, Inc.
|
K222902 |
07/28/2023
|
electrocardiograph
|
Edan Instruments, Inc.
|
K212278 |
04/07/2022
|
patient monitor
|
Edan Instruments, Inc.
|
K202336 |
01/23/2021
|
patient monitor
|
Edan Instruments, Inc.
|
K192514 |
04/02/2020
|
electrocardiograph
|
Edan Instruments, Inc.
|
K171942 |
01/24/2018
|
electrocardiograph
|
Edan Instruments, Inc.
|
K171943 |
09/25/2017
|
electrocardiograph
|
Edan Instruments, Inc.
|
K170995 |
06/02/2017
|
pc ecg
|
EDAN INSTRUMENTS, INC.
|
K160876 |
02/15/2017
|
telemetry transmitter
|
Edan Instruments, Inc.
|
K161056 |
02/03/2017
|
patient monitor
|
EDAN INSTRUMENTS, INC.
|
K160981 |
12/22/2016
|
|