Inovise Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Inovise Medical, Inc. makes
Inovise Medical, Inc. makes medical devices such as the AUDICOR 200 SYSTEM, an ECG interpretative software called CARDIOVISE, and various models of the AUDICOR SENSOR. These devices are used for monitoring and measuring cardiac and pulmonary activity, including ambulatory monitoring and sleep disordered breathing detection.
The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry. Inovise Medical, Inc. is based in the US.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 1 recall initiated by Inovise Medical, Inc., initiated on 2003-01-12. By recorded status: 1 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2003
- 12 Jan 2003 Z-0565-06 Unclassified (pre-2012) Terminated 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.
Frequently asked questions
How many devices does Inovise Medical, Inc. have in the registry?
The registry currently lists 14 devices for Inovise Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inovise Medical, Inc.'s devices?
Among its 14 most recently registered devices, Inovise Medical, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Inovise Medical, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Inovise Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Inovise Medical, Inc.?
FDA recall records list 1 recall initiated by Inovise Medical, Inc., the most recent initiated on 12 Jan 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Inovise Medical, Inc. in the registry?
The most recently registered devices listed for Inovise Medical, Inc. include AUDICOR 200 SYSTEM, MODELS 200D AND 200S, CARDIOVISE ECG INTERPRETATIVE SOFTWARE, EXTENDED MEASUREMENTS SYSTEM and AUDICOR SENSOR, MODELS: 2.0, 3.0.