Company ยท US
Somanetics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2010. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2010 | K093422 | VITAL SYNC MODEL 5000 SERIES Somanetics Corp. | MWI |
| Jul 9, 2009 | K091224 | OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S Somanetics Corp. | MUD |
| Apr 3, 2009 | K082327 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C Somanetics Corp. | MUD |
| May 14, 2008 | K080769 | INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C Somanetics Corp. | MUD |
| Nov 4, 2005 | K051274 | INVOS SYSTEM Somanetics Corp. | MUD |
| Mar 16, 2004 | K040162 | CORRESTORE PATCH SYSTEM Somanetics Corp. | DXZ |
| Aug 7, 2003 | K031586 | CORRESTORE PATCH SYSTEM Somanetics Corp. | DXZ |
| Nov 21, 2001 | K011487 | CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS Somanetics Corp. | DXZ |
| Sep 15, 2000 | K001842 | ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 Somanetics Corp. | DQA |
| Oct 10, 1997 | K971628 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) Somanetics Corp. | DQA |
| Jun 5, 1996 | K960614 | SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) Somanetics Corp. | DQA |
| May 18, 1990 | K892217 | CAV SAT OXIMETER MODEL 100 Somanetics Corp. | DQA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||