FDA 510(k) Applications Submitted by DAVID J VANELLA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K121497 |
05/21/2012 |
VENOFER PUMP |
RENAL SOLUTIONS INC. |
| K212530 |
08/11/2021 |
IVX Fluid Transfer Set |
Omnicell, Inc. |
| K103564 |
12/06/2010 |
VENOFER PUMP |
RENAL SOLUTIONS, INC. |
| K123835 |
12/13/2012 |
2008 HEMODIALYSIS SORBENT SYSTEM |
RENAL SOLUTIONS, INC. |
| K093964 |
12/24/2009 |
VENOFER PUMP |
RENAL SOLUTIONS INC. |
| K010052 |
01/08/2001 |
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER |
RESPIRONICS, INC. |
| K010263 |
01/29/2001 |
REMSTAR PLUS CPAP SYSTEM |
RESPIRONICS, INC. |
| K060381 |
02/14/2006 |
ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 |
RENAL SOLUTIONS, INC. |
| K990574 |
02/23/1999 |
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 |
RESPIRONICS, INC. |
| K000705 |
03/02/2000 |
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 |
RESPIRONICS, INC. |
| K070739 |
03/16/2007 |
ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 |
RENAL SOLUTIONS INC. |
| K000994 |
03/28/2000 |
BIPAP DUET LX BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
| K991648 |
05/13/1999 |
REUSABLE CONTOUR II NASAL MASK |
RESPIRONICS, INC. |
| K011714 |
06/04/2001 |
BIPAP PRO BI-LEVEL SYSTEM |
RESPIRONICS, INC. |
| K992336 |
07/13/1999 |
MONARCH II MINI MASK |
RESPIRONICS, INC. |
| K012323 |
07/23/2001 |
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
| K992530 |
07/28/1999 |
BIPAP SYNCHRONY HC |
RESPIRONICS, INC. |
| K012554 |
08/08/2001 |
REMSTAR AUTO CPAP SYSTEM |
RESPIRONICS, INC. |
| K002465 |
08/11/2000 |
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 |
RESPIRONICS, INC. |
| K012633 |
08/13/2001 |
RESPIRONICS HEATED HUMIDIFIER |
RESPIRONICS, INC. |
| K992969 |
09/03/1999 |
RESPIRONICS TOTAL FACE MASK |
RESPIRONICS, INC. |
| K993307 |
10/04/1999 |
ARIA LX CPAP SYSTEM |
RESPIRONICS, INC. |
| K993433 |
10/12/1999 |
VIRTUOSO LX SMART CPAP SYSTEM |
RESPIRONICS, INC. |
| K093362 |
10/28/2009 |
2008 HEMODIALYSIS SORBENT SYSTEM |
RENAL SOLUTIONS INC. |
| K003499 |
11/13/2000 |
REMVIEW SLEEP RECORDER, MODEL 320 |
RESPIRONICS, INC. |
| K984407 |
12/09/1998 |
BIPAP HARMONY S/T, MODEL 1001445 |
RESPIRONICS, INC. |
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