FDA 510(k) Applications Submitted by JI HEE KO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K163334 |
11/28/2016 |
LiDCOunity v2 Hemodynamic Monitor |
LiDCO Ltd |
| K121105 |
04/12/2012 |
NUTRISAFE 2 FEEDING TUBE |
VYGON CORP. |
| K141026 |
04/22/2014 |
LEADERFLEX |
VYGON |
| K181208 |
05/07/2018 |
Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter |
Vygon USA |
| K151237 |
05/11/2015 |
Nutrisafe 2- ENFit Adaptor |
VYGON |
| K172899 |
09/22/2017 |
Vygon PICCs |
Vygon USA |
| K080533 |
02/26/2008 |
WINCO MODEL POWER SERIES LIFT CHAIR |
WINCO, INC. |
| K110671 |
03/09/2011 |
WINCO STRETCHAIR |
WINCO MFG., LLC |
| K974454 |
11/25/1997 |
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 |
TUCSON MEDICAL CORP. |
| K961982 |
05/20/1996 |
TRI-FLOW THREE WAY STOPCOCK |
NORTH, INC. |
| K110213 |
01/25/2011 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
| K090233 |
01/30/2009 |
GE DATEX-OHMEDA AISYS |
DATEX-OHMEDA, INC. |
| K112722 |
09/19/2011 |
GE DATEX-OHMEDA AVANCE |
DATEX-OHMEDA, INC. |
| K093886 |
12/18/2009 |
ENGSTROM CARESTATION, ENGSTROM PRO |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
| K161776 |
06/29/2016 |
Lenstec LC Injection system |
LENSTEC INC. |
| K091915 |
06/30/2009 |
FLUID ISOLATION DEVICE |
LENSTEC, INC. |
| K122848 |
09/18/2012 |
LENSTEC LC INJECTION SYSTEM |
LENSTEC, INC. |
| K063802 |
12/22/2006 |
LENSTEC LC INJECTION SYSTEM |
LENSTEC, INC. |
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