FDA 510(k) Applications Submitted by GINA TO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180637 |
03/12/2018 |
leva Pelvic Floor Trainer |
Renovia Inc. |
| K192270 |
08/22/2019 |
LEva Pelvic Digital Health System |
Renovia Inc. |
| K020357 |
02/04/2002 |
800 SERIES EASYNEB NEBULIZER |
NELLCOR PURITAN BENNETT, INC. |
| K120527 |
02/22/2012 |
ALPHA ORTHOPAEDICS AT2 SYSTEM |
ALPHA ORTHOPAEDICS, INC |
| K020604 |
02/25/2002 |
WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300 |
NELLCOR PURITAN BENNETT, INC. |
| K030787 |
03/12/2003 |
SHILEY FLEXTRA TRACHEOSTOMY TUBE |
NELLCOR PURITAN BENNETT, INC. |
| K030930 |
03/25/2003 |
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N |
NELLCOR PURITAN BENNETT, INC. |
| K021089 |
04/04/2002 |
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR |
NELLCOR PURITAN BENNETT, INC. |
| K021090 |
04/04/2002 |
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER |
NELLCOR PURITAN BENNETT, INC. |
| K021573 |
05/14/2002 |
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION |
PURITAN-BENNETT |
| K022819 |
08/26/2002 |
NELLCOR N-200 PULSE OXIMETER, MODEL N-200 |
NELLCOR PURITAN BENNETT, INC. |
| K023225 |
09/27/2002 |
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE |
PURITAN BENNETT CORP. |
| K082956 |
10/03/2008 |
ALPHA ORTHOPAEDICS AT2 SYSTEM |
ALPHA ORTHOPAEDICS |
| K023494 |
10/18/2002 |
NELLCOR INDGO MANUAL RESUSCITATOR |
NELLCOR PURITAN BENNETT, INC. |
| K094041 |
12/30/2009 |
ALPHA ORTHOPAEDICS AT3 SYSTEM |
ALPHA ORTHOPAEDICS |
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