FDA 510(k) Applications Submitted by Nonin Medical, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140785 |
03/31/2014 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K131021 |
04/12/2013 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K132402 |
08/01/2013 |
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM |
NONIN MEDICAL, INC. |
| K112843 |
09/29/2011 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K113215 |
11/01/2011 |
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY |
NONIN MEDICAL, INC. |
| K945290 |
10/31/1994 |
8500A PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K040589 |
03/08/2004 |
MODIFICATION TO AVANT 9600 PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K041156 |
05/03/2004 |
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 |
NONIN MEDICAL, INC. |
| K033307 |
10/14/2003 |
NVISION DATA MANAGEMENT SOFTWARE |
NONIN MEDICAL, INC. |
| K043359 |
12/06/2004 |
4100 PATIENT OXIMETER MODULE |
NONIN MEDICAL, INC. |
| K192900 |
10/15/2019 |
H500 Multi-Sensing Oximetry System |
Nonin Medical, Inc. |
| K160231 |
02/01/2016 |
Model X-100C CO-MetÖ Oximetry System |
NONIN MEDICAL, INC. |
| K050056 |
01/11/2005 |
MODEL 2500A PALMSAT PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K092101 |
07/14/2009 |
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES |
NONIN MEDICAL, INC. |
| K052829 |
10/05/2005 |
WRISTOX MODEL 3100 PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K093306 |
10/22/2009 |
SINGLE-PATIENT USE DISPOSABLE SENSOR |
NONIN MEDICAL, INC. |
| K093853 |
12/16/2009 |
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES |
NONIN MEDICAL, INC. |
| K102350 |
08/19/2010 |
PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K102715 |
09/20/2010 |
REGIONAL OXIMETER |
NONIN MEDICAL, INC. |
| K080255 |
01/31/2008 |
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K090807 |
03/25/2009 |
REGIONAL OXIMETER SYSTEM, MODEL 7600 |
NONIN MEDICAL, INC. |
| K051107 |
05/02/2005 |
ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
NONIN MEDICAL, INC. |
| K081285 |
05/06/2008 |
FINGER PULSE OXIMETER, MODEL 9560 |
NONIN MEDICAL, INC. |
| K071285 |
05/07/2007 |
DIGITAL PULSE OXIMETER, MODEL 7500 |
NONIN MEDICAL, INC. |
| K071415 |
05/21/2007 |
DIGITAL PULSE OXIMETER, MODEL 7500FO |
NONIN MEDICAL, INC. |
| K092678 |
09/01/2009 |
EVISION DATA MANAGEMENT SOFTWARE |
NONIN MEDICAL, INC. |
| K052669 |
09/27/2005 |
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 |
NONIN MEDICAL, INC. |
| K053130 |
11/08/2005 |
ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
NONIN MEDICAL, INC. |
| K063752 |
12/19/2006 |
LIFESENSE, MODEL LS1-9R |
NONIN MEDICAL, INC. |
| K190560 |
03/05/2019 |
SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface |
Nonin Medical, Inc. |
| K160865 |
03/30/2016 |
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C S |
NONIN MEDICAL, INC. |
| K030668 |
03/03/2003 |
MODEL 3100 WRISTOX PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K001085 |
04/04/2000 |
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 |
NONIN MEDICAL, INC. |
| K031487 |
05/12/2003 |
MODEL AVANT 2120 PULSE OXIMETER AND NIBP |
NONIN MEDICAL, INC. |
| K001930 |
06/26/2000 |
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 |
NONIN MEDICAL, INC. |
| K982969 |
08/25/1998 |
NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847 |
NONIN MEDICAL, INC. |
| K002690 |
08/29/2000 |
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 |
NONIN MEDICAL, INC. |
| K023044 |
09/12/2002 |
MODEL 9600, AVANT PULSE OXIMETER |
NONIN MEDICAL, INC. |
| K013319 |
10/05/2001 |
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR |
NONIN MEDICAL, INC. |
| K191403 |
05/24/2019 |
Pulse Oximeter |
Nonin Medical, Inc. |
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