Carleton Life Support Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Carleton Life Support Systems, Inc. makes
Carleton Life Support Systems, Inc. manufactures patient ventilation oxygen concentrating systems, high flow (PVOCS HF), deployable oxygen generation systems - medium (DOGS-M), and aircraft medical oxygen generation systems (AMOGS).
The company's devices are listed in the FDA 510(k) registry and are classified as Class II medical devices. Carleton Life Support Systems, Inc. is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Carleton Life Support Systems, Inc., initiated on 2009-07-24. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 24 Jul 2009 Z-2009-2009 Unclassified (pre-2012) Terminated The backup oxygen supply control valve on the oxygen concentrator could fail resulting in it sticking in the open or closed positions.
Frequently asked questions
How many devices does Carleton Life Support Systems, Inc. have in the registry?
The registry currently lists 3 devices for Carleton Life Support Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carleton Life Support Systems, Inc.'s devices?
Among its 3 most recently registered devices, Carleton Life Support Systems, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Carleton Life Support Systems, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Carleton Life Support Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Carleton Life Support Systems, Inc.?
FDA recall records list 1 recall initiated by Carleton Life Support Systems, Inc., the most recent initiated on 24 Jul 2009. 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 Carleton Life Support Systems, Inc. in the registry?
The most recently registered devices listed for Carleton Life Support Systems, Inc. include PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF), DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) and AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS).