FDA 510(k) Applications Submitted by LARRY A LEPLEY
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K090212 |
01/28/2009 |
MAC 800 RESTING ECG ANALYSIS SYSTEM |
GE MEDICAL SYST. INFORMATION TECHNOLOGIES |
K110344 |
02/04/2011 |
INOMAX DSIR (DELIVERY SYSTEM) |
INO THERAPEUTICS |
K970769 |
03/03/1997 |
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR |
ARISTO MEDICAL |
K110635 |
03/04/2011 |
INOMAX DS(IR) (DELIVERY SYSTEM) |
INO THERAPEUTICS LLC/DBA IKARIA |
K092545 |
08/19/2009 |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS LLC |
K043018 |
11/02/2004 |
OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 |
OMRON HEALTHCARE, INC. |
K113272 |
11/04/2011 |
INOMAX DS(DELIVERY SYSTEMS |
INO THERAPEUTICS LLC/DBA IKARIA |
K043060 |
11/05/2004 |
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 |
OMRON HEALTHCARE, INC. |
K083639 |
12/09/2008 |
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
K093922 |
12/22/2009 |
INOMAX DS |
INO THERAPEUTICS |
K942685 |
06/07/1994 |
ECG REVIEW STATION |
MORTARA INSTRUMENT, INC. |
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