Cardiopulmonary Instrumentation
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cardiopulmonary Instrumentation makes
Cardiopulmonary Instrumentation manufactures cardiac output computers, which measure and calculate the volume of blood pumped by the heart per minute using physiological signals.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Cardiac Output Computer Ref K760600
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Cardiopulmonary Instrumentation, initiated on 2011-02-17. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 17 Feb 2011 Z-1013-2012 Unclassified (pre-2012) Terminated Cardiopulmonary Instrumentation, Inc. dba CI Healthcare, Miami, FL, is recalling their Stainless Steel Patient Transport Stretcher, model # CI-8092, Lot 002, because of a malfunction that occurs when weight is applied to the backrest. This malfunction causes the backrest support bar, when secured in the first hook, to fall to a flat position.
Frequently asked questions
How many devices does Cardiopulmonary Instrumentation have in the registry?
The registry currently lists 1 device for Cardiopulmonary Instrumentation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiopulmonary Instrumentation's devices?
Among its 1 most recently registered device, Cardiopulmonary Instrumentation has devices listed in FDA 510(k) (1 device).
What risk classes do Cardiopulmonary Instrumentation's devices fall under?
Among its 1 most recently registered device, the classes recorded for Cardiopulmonary Instrumentation's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cardiopulmonary Instrumentation?
FDA recall records list 1 recall initiated by Cardiopulmonary Instrumentation, the most recent initiated on 17 Feb 2011. 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 Cardiopulmonary Instrumentation in the registry?
The most recently registered devices listed for Cardiopulmonary Instrumentation include CARDIAC OUTPUT COMPUTER.