Inovise Medical, Inc.
Newberg, OR, US
Inovise Medical, Inc. appears in FDA device records in Newberg, OR. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Inovise Medical, Inc. between 2000 and 2016. The busiest year on record is 2003, with 2. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2003 | 2 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K151433 | AUDICOR CA300/CC100 Analyzer with SDB | MNR | Substantially Equivalent | |
| K131883 | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) | MNR | Substantially Equivalent | |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | MLO | Substantially Equivalent | |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | MLO | Substantially Equivalent | |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | MLO | Substantially Equivalent | |
| K103516 | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 | DQD | Substantially Equivalent | |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | DRX | Substantially Equivalent | |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | MWJ | Substantially Equivalent | |
| K070136 | AUDICOR 200 SYSTEM, MODELS 200D AND 200S | DPS | Substantially Equivalent | |
| K051450 | EXTENDED MEASUREMENTS SYSTEM | DQD | Substantially Equivalent | |
| K043074 | LIBERTY SYSTEM | DPS | Substantially Equivalent | |
| K032145 | AUDICOR UPGRADE SYSTEM | DPS | Substantially Equivalent | |
| K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) | DRX | Substantially Equivalent | |
| K001349 | CARDIOVISE ECG INTERPRETATIVE SOFTWARE | MWJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0565-06 | AUDICOR 200 D Inovise Part Number 30047 (console part number 20158). | Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain