Company ยท US
Inovise Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2016. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 2016 | K151433 | AUDICOR CA300/CC100 Analyzer with SDB Inovise Medical, Inc. | MNR |
| Apr 11, 2014 | K131883 | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) Inovise Medical, Inc. | MNR |
| Oct 11, 2013 | K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) Inovise Medical, Inc. | MLO |
| Sep 20, 2012 | K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) Inovise Medical, Inc. | MLO |
| Oct 24, 2011 | K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) Inovise Medical, Inc. | MLO |
| Feb 4, 2011 | K103516 | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 Inovise Medical, Inc. | DQD |
| Sep 25, 2008 | K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 Inovise Medical, Inc. | DRX |
| Sep 9, 2008 | K073545 | AUDICOR, HEMO AMBULATORY MONITOR Inovise Medical, Inc. | MWJ |
| Apr 13, 2007 | K070136 | AUDICOR 200 SYSTEM, MODELS 200D AND 200S Inovise Medical, Inc. | DPS |
| Nov 10, 2005 | K051450 | EXTENDED MEASUREMENTS SYSTEM Inovise Medical, Inc. | DQD |
| Feb 22, 2005 | K043074 | LIBERTY SYSTEM Inovise Medical, Inc. | DPS |
| Oct 31, 2003 | K032145 | AUDICOR UPGRADE SYSTEM Inovise Medical, Inc. | DPS |
| Aug 7, 2003 | K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) Inovise Medical, Inc. | DRX |
| Jul 27, 2000 | K001349 | CARDIOVISE ECG INTERPRETATIVE SOFTWARE Inovise Medical, Inc. | MWJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2006 | Inovise Medical, Inc. AUDICOR 200 D Inovise Part Number 30047 (console part number 20158). Terminated |
DPS | K043074 |